Clinical evaluation of ultrasonic subgingival debridement and ultrasonic subgingival scaling combined with manual root planning in patients with periodontitis: study protocol for a randomized controlled trial

Abstract Background: Periodontal diseases are regarded as the most common diseases of mankind. The prevalence rate of periodontal disease assumes the obvious growth tendency in the whole world, increased by 57.3% from 1990 to 2010. Thereby, effective periodontal therapy is still a long-term task and tricky problem. The goals of periodontal therapy are to eliminate the infectious and inflammatory processes. Root planning, in order to eliminate the “infected cementum”, is an important step in treatment of periodontitis since 1970s. Along with the understanding of endotoxin’s feature on root surface, the necessity of manual root planing has been gradually queried. Ultrasonic instruments wouldn’t remove the cementum excessively, which are more time-saving and labor-saving compared to hand instruments as well. Hence, an increasing number of dentists prefer to scaling with ultrasonic instruments only. However, the necessity of root planing has still been emphasized in the international mainstream views of periodontal mechanical treatment. Therefore, this study is devoted to compare the clinical effect of ultrasonic subgingival debridement and ultrasonic subgingival scaling combined with manual root planing, which taking the implementation of root planing as the only variable and more in line with the clinical situation, hoping to provide some reference to dentists. Methods/design: Forty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology (Beijing, China). By means of randomization tables, one quadrant of the upper and lower teeth is the test group and the other is the control group. Test group: ultrasonic subgingival scaling combined with manual root planing. Control group: ultrasonic subgingival debridement. In a 24-weeks follow-up period, plaque index, probing depth, clinical attachment loss, bleeding index, furcation involvement, mobility, and patient-reported outcome (visual analog scale for pain and sensitivity) will be observed and documented. Discussion: This study evaluates the effectiveness of ultrasonic subgingival scaling combined with manual root planing and ultrasonic subgingival debridement alone in nonsurgical treatment of periodontitis with a split-mouth design after 1, 3 and 6 months. The result of the trial will potentially contribute to an advanced treatment strategy of periodontitis with ideal clinical outcome. Trial registration: The study has been registered in International Clinical Trials Registry Platform (ICTRP) under the identifier number ChiCTR1800017122. Registered on 12 July 2018. Keywords: Peridontitis, Non-surgical periodontal therapy, Ultrasonic subgingival debridement, Root planing

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Clinical evaluation of ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing in the treatment of periodontitis: study protocol for a randomized controlled trial

10.21203/rs.2.11786/v2 ◽

2019 ◽

Author(s):

Yue Yan ◽

Yalin Zhan ◽

Xian'e Wang ◽

Jianxia Hou

Keyword(s):

Periodontal Diseases ◽

Controlled Trial ◽

Test Group ◽

Periodontal Therapy ◽

University Hospital ◽

Control Group ◽

Clinical Attachment Loss ◽

Root Planing ◽

Patient Reported ◽

Subgingival Scaling

Abstract Background: Periodontal diseases are regarded as the most common diseases of mankind. The prevalence rate of periodontal disease assumes the obvious growth tendency in the whole world, increased by 57.3% from 1990 to 2010. Thereby, effective periodontal therapy is still a long-term task and tricky problem. The goals of periodontal therapy are to eliminate the infectious and inflammatory processes. Root planing, in order to eliminate the “infected cementum”, is an important step in treatment of periodontitis since 1970s. Along with the understanding of endotoxin’s feature on root surface, the necessity of manual root planing has been gradually queried. Ultrasonic instruments wouldn’t remove the cementum excessively, which are more time-saving and labor-saving compared to hand instruments as well. Hence, an increasing number of dentists prefer to scaling with ultrasonic instruments only. However, the necessity of root planing has still been emphasized in the international mainstream views of periodontal mechanical treatment. Therefore, this study is devoted to compare the clinical effect of ultrasonic subgingival debridement and ultrasonic subgingival scaling combined with manual root planing, which taking the implementation of root planing as the only variable and more in line with the clinical situation, hoping to provide some reference to dentists. Methods/design: Forty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology (Beijing, China). By means of randomization tables, one quadrant of the upper and lower teeth is the test group and the other is the control group. Test group: ultrasonic subgingival scaling combined with manual root planing. Control group: ultrasonic subgingival debridement. In a 24-weeks follow-up period, plaque index, probing depth, clinical attachment loss, bleeding index, furcation involvement, mobility, and patient-reported outcome (visual analog scale for pain and sensitivity) will be observed and documented. Discussion: This study evaluates the effectiveness of ultrasonic subgingival scaling combined with manual root planing and ultrasonic subgingival debridement alone in nonsurgical treatment of periodontitis with a split-mouth design after 1, 3 and 6 months. The result of the trial will potentially contribute to an advanced treatment strategy of periodontitis with ideal clinical outcome. Trial registration: The study has been registered in International Clinical Trials Registry Platform (ICTRP) under the identifier number ChiCTR1800017122. Registered on 12 July 2018. Keywords: Peridontitis, Non-surgical periodontal therapy, Ultrasonic subgingival debridement, Root planing

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Study of the Antimicrobial Effect of an Ethanolic Extract of Propolis in Periodontal Disease

Applied Sciences ◽

10.3390/app11167463 ◽

2021 ◽

Vol 11 (16) ◽

pp. 7463

Author(s):

Maria Jesús Lisbona-González ◽

Esther Muñoz-Soto ◽

Candela Reyes-Botella ◽

Maria Victoria Olmedo-Gaya ◽

Javier Diaz-Castro ◽

...

Keyword(s):

Periodontal Disease ◽

Therapeutic Potential ◽

Periodontal Diseases ◽

Test Group ◽

Periodontal Therapy ◽

Control Group ◽

Clinical Parameters ◽

Scaling And Root Planing ◽

Root Planing ◽

Supportive Periodontal Therapy

Periodontal disease encompasses gingivitis and periodontitis and is one of the most common chronic infections in the adult population. This study aimed to evaluate the influence of Spanish propolis extract (EEP) on the effect of the clinical and microbiological parameters as an adjuvant to scaling and root planning in patients undergoing supportive periodontal therapy (SPT). Forty chronic periodontitis patients were randomly assigned into two groups for the treatment. In the control group (n = 20), the sites were treated by scaling and root planing followed by gingival irrigation with physiological saline and in the test group (n = 20), the sites were treated by scaling and root planing followed by subgingival placement of EEP. At baseline (BL), bleeding on probing positive (BOP+) sites with probing pocket (PPD) ≥ 4 mm were defined as study sites. Plaque index, PPD, BOP, clinical attachment level (CAL), and subgingival plaque were evaluated at BL and 1 month later. The results showed a significant clinical improvement (p < 0.05) in the PPD, CAL and BOP+ comparing them with BL and one month after the periodontal treatment and a significant reduction (p < 0.05) for Tannerella forsythensis, Porphyromonas gingivalis, Prevotella intermedia and Treponema denticola in both groups. In addition, the improvement of clinical parameters was observed with subgingival use of EEP and also statistically significant differences between groups were observed (p < 0.05) such as reductions of BOP+ % and reduced counts of T. forsythensis and P. gingivalis, considered as the “key pathogens” for the periodontal diseases. Our results suggest prophylactic and therapeutic potential for EEP against periodontal diseases, improving clinical parameters, reducing gingival bleeding and decreasing bacterial counts of T. forsythensis and P. gingivalis. The subgingival use of EEP represents a promising modality as an adjuvant in periodontal therapy to avoid microbial resistance and other adverse effects.

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Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults

European Journal of Orthodontics ◽

10.1093/ejo/cjy082 ◽

2019 ◽

Vol 41 (5) ◽

pp. 495-501 ◽

Cited By ~ 11

Author(s):

Carole Charavet ◽

Geoffrey Lecloux ◽

Nastasia Jackers ◽

Adelin Albert ◽

France Lambert

Keyword(s):

Orthodontic Treatment ◽

Treatment Time ◽

Controlled Trial ◽

Test Group ◽

University Hospital ◽

Control Group ◽

Orthodontic Appliances ◽

Overall Treatment Time ◽

Randomized Controlled ◽

Cad Cam

Summary Objective The aim of this study was to investigate the effects of piezocision (surgical protocol with sutures) in orthodontic treatment using CAD/CAM (computer-aided design and computer-aided manufacturing) customized orthodontic appliances. Design The study is designed as a parallel group, randomized controlled trial (RCT). Setting University Hospital. Ethical approval The study was approved by the ethic committee of the University Hospital Liege, Belgium. Subjects and methods This RCT was conducted on 24 adult patients requiring orthodontic treatment to release mild overcrowding. Patients were all treated with a customized appliance and randomly assigned by means of sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment. A blinded orthodontist validated appliance removal or further adjustments based on the model study. Outcome measures The overall treatment time and the time between archwire changes were recorded. Moreover, clinical and radiological features such as tooth resorption, gingival recessions, and the presence of scars were evaluated. Results A total of 24 patients (12 control and 12 test) completed the study. The overall treatment time was significantly shorter in the test group than the control group. Likewise, the time difference between all arch changes was significantly lower when piezocision was performed, except for the first arch at the mandible and the last arches at both maxillae. During the fine-tuning phase, no significant difference was found between the two groups. All periodontal and radiographic parameters remained stable from the start to the end of treatment in both the groups. However, minor scars were found in 66 per cent cases. Limitations This trial was a single-centre trial. Conclusions Piezocision seems to be an effective method to accelerate orthodontic treatment in cases of mild overcrowding. However, the effect was only observed during the alignment phase and a greater efficiency was found in the maxilla. The technique may be contraindicated in patients with a high smile line since the risk of slight scarring exists. Registration ClinicalTrails.gov (Identifier: NCT03406130)

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Effect of advanced periodontal self-care in patients with early-stage periodontal diseases on endothelial function: An open-label, randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0257247 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0257247

Author(s):

Ayako Okada ◽

Takatoshi Murata ◽

Khairul Matin ◽

Meu Ariyoshi ◽

Ryoko Otsuka ◽

...

Keyword(s):

Early Stage ◽

Periodontal Diseases ◽

Controlled Trial ◽

Self Care ◽

Test Group ◽

Control Group ◽

Atherosclerotic Cardiovascular Disease ◽

Adma Level ◽

Open Label ◽

Randomized Controlled

Although a significant association between periodontal disease and atherosclerotic cardiovascular disease has been reported, their cause-to-effect relationship remains controversial. This randomized controlled clinical trial aimed to investigate the effect of advanced self-care on atherosclerotic cardiovascular disease-related vascular function markers flow-mediated brachial artery dilatation (FMD) and serum asymmetric dimethylarginine (ADMA) level in patients with early-stage periodontal disease. The study was designed as a parallel group, 3-month follow-up, open-label, randomized controlled trial. The control group received standard care for periodontal diseases, whereas the test group additionally applied disinfectant using a custom-fabricated prescription tray for advanced self-care twice a day. Overall, 110 patients provided data for FMD and serum ADMA level. No significant improvements in FMD were observed in the control (mean increase, −0.1%; 95% confidence interval [CI], −1.0–0.8; P = 0.805) or test (mean increase, −0.3%; 95% CI, −1.1–0.4; P = 0.398) group. No significant changes in serum ADMA levels were observed (mean reduction, 0.01 μmol/L; 95% CI, −0.00–0.02; P = 0.366 and mean reduction, 0.00 μmol/L; 95% CI, −0.01–0.01; P = 0.349, respectively). No significant between-group differences were found in FMD (mean difference, −0.2%; 95% CI, −1.4–0.9; p = 0.708) or serum ADMA levels (mean difference, 0.01 nmol/L; 95% CI, −0.00–0.03; p = 0.122). Significant improvements in the average probing pocket depth were observed in the control and test groups. The bleeding on probing score in the test group was significantly reduced, while that in the control group was reduced, although not significantly. Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases. This trial is registered in UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/; ID: UMIN000023395).

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Efficacy of nano-carbonate apatite dentifrice in relief from dentin hypersensitivity following non-surgical periodontal therapy: A randomized controlled trial

10.21203/rs.2.16742/v1 ◽

2019 ◽

Author(s):

Pei-Hui Ding ◽

Anna Dai ◽

Hua-Jiao Hu ◽

Jia-Ping Huang ◽

Jia-Mei Liu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Test Group ◽

Periodontal Therapy ◽

Control Group ◽

Carbonate Apatite ◽

Dentine Hypersensitivity ◽

Randomized Controlled ◽

At Home

Abstract Background: Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules. It has been demonstrated that nano-sized particles could seal these the dentine tubules. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. Methods: 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. Results: 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for VAS, test group: 0.66 ± 0.68 versus control group: 0.84 ± 0.78, p = 0.005; for Schiff score, test group: 0.69 ± 0.71 versus control group: 0.97 ± 0.77, p < 0.001). Conclusions: Home-use of n-CAP based dentifrice provided a significantly better alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. Trail registration: Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017)

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Efficacy of nano-carbonate apatite dentifrice in relief from dentin hypersensitivity following non-surgical periodontal therapy: A randomized controlled trial

10.21203/rs.2.16742/v2 ◽

2020 ◽

Author(s):

Pei-Hui Ding ◽

Anna Dai ◽

Hua-Jiao Hu ◽

Jia-Ping Huang ◽

Jia-Mei Liu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Test Group ◽

Periodontal Therapy ◽

Control Group ◽

Dentin Hypersensitivity ◽

Carbonate Apatite ◽

Dentine Hypersensitivity ◽

Randomized Controlled

Abstract Background: Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules, but currently no gold standard exists to treat DH. It has been demonstrated that nano-sized particles presented potential for dentine tubules blocking and remineralization. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. Methods: 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. Results: 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for change of VAS, test group: 2.27 ± 2.47 versus control group: 1.68 ± 2.24, p = 0.036; for change of Schiff, test group: 0.94 ± 0.92 versus control group: 0.61 ± 0.83, p < 0.001). The 6-week results showed borderline significance between groups in terms of change of Schiff (p = 0.027) and no significance in terms of change of VAS (p = 0.256). Conclusions: Home-use of n-CAP based dentifrice had some benefit on alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. Trial registration: Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017) Keywords: dentin hypersensitivity; dentifrices; randomized controlled trial; periodontitis

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Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

Journal of Clinical Oncology ◽

10.1200/jco.2010.30.3909 ◽

2011 ◽

Vol 29 (8) ◽

pp. 1029-1035 ◽

Cited By ~ 204

Author(s):

Donna L. Berry ◽

Brent A. Blumenstein ◽

Barbara Halpenny ◽

Seth Wolpin ◽

Jesse R. Fann ◽

...

Keyword(s):

Controlled Trial ◽

Clinic Visit ◽

Self Report ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Control Group ◽

Cancer Symptoms ◽

Patient Reported ◽

Life Issues ◽

Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

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Clinical efficacy of scaling and root planing with and without metronidazole on glycemic control: three-arm randomized controlled trial

BMC Oral Health ◽

10.1186/s12903-021-01620-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ambrina Qureshi ◽

Syed Akhtar Hussain Bokhari ◽

Zeba Haque ◽

Akhtar Ali Baloch ◽

Sidra Zaheer

Keyword(s):

Randomized Controlled Trial ◽

Glycemic Control ◽

Clinical Efficacy ◽

Controlled Trial ◽

Test Group ◽

Periodontal Pocket ◽

Outcome Variable ◽

Scaling And Root Planing ◽

Randomized Controlled ◽

Root Planing

Abstract Background Treating periodontitis through non-surgical periodontal therapy (NSPT) may improve glycemic control in type-2 Diabetes Mellitus (T2DM) patients. However, the evidence to maintain this improvement beyond four months is insufficient. Hence, this trial was conducted to assess clinical efficacy of NSPT on glycemic control in T2DM patients. Methods This three-arm randomized controlled trial recruited 150 known T2DM participants (35–65 years), suffering from moderate to severe periodontitis, having HbA1c level ≥ 6.5% at baseline. Participants were followed up at 3 and 6 months. Intervention for test group-1 included scaling and root planing (SRP) with metronidazole (MET) and oral hygiene instructions (OHI). Test group-2 was intervened with SRP + OHI and control group with OHI only. Stata v. 14 was used to observe inter and intragroup mean changes in glycemic [glycated hemoglobin (HbA1c), fasting blood glucose (FBG)] and periodontal variables [bleeding on probing (BOP), periodontal pocket depth (PPD), clinical attachment loss (CAL)] using ANOVA and RMANOVA. Proportion of change in outcome variable (HbA1c) was assessed between treatment groups using chi-square test. Change was considered significant at p-value ≤ 0.05. Results A significant reduction was observed in BOP, PPD, CAL, HbA1c and FBG over time [p < 0.05]. Significant reductions were observed in same variables in both test groups in comparison to control arm [p < 0.05]. No change between the two test groups was observed [p > 0.05]. Conclusion Scaling and root planing improves glycemic control of T2DM patients independently of the use of MET. Therefore, SRP after every 6 months may be suggested and included as a part of overall diabetes management for patients suffering from T2DM. Clinical trial registration NCT 03,343,366 [Date of Registration: 17/11/2017]

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Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial

BMC Health Services Research ◽

10.1186/s12913-021-06223-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Urška Nabergoj Makovec ◽

Igor Locatelli ◽

Mitja Kos

Keyword(s):

Medication Adherence ◽

Controlled Trial ◽

Test Group ◽

Multiple Linear Regression Model ◽

Relative Difference ◽

Control Group ◽

Adherence Support ◽

Medicines Use ◽

The Impact ◽

Medicines Use Review

Abstract Background Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. Methods A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. Results Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16–2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05–1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = − 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. Conclusion MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. Trial registration ClinicalTrials.gov - NCT04417400; 4th June 2020; retrospectively registered.

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Clinical and Immunological Efficacy of Mangosteen and Propolis Extracted Complex in Patients with Gingivitis: A Multi-Centered Randomized Controlled Clinical Trial

Nutrients ◽

10.3390/nu13082604 ◽

2021 ◽

Vol 13 (8) ◽

pp. 2604

Author(s):

Jin-Young Park ◽

Kyung-A Ko ◽

Ji-Yeong Lee ◽

Jae-Woon Oh ◽

Hyun-Chang Lim ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Daily Intake ◽

Test Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Control Groups ◽

Immunological Parameters ◽

Significant Difference ◽

Patient Reported ◽

And Control

Background: Mangosteen and propolis extracts (MAEC) have been potential therapeutic agents known to exhibit powerful antioxidant and anti-inflammatory properties. The aim of the current study was to evaluate the clinical and immunological efficacy of MAEC as well as safety and patient-reported outcomes (PROMs) on gingivitis and incipient periodontitis. Methods: This study was performed on 104 patients diagnosed with gingivitis or incipient periodontitis. At baseline, the participants were randomly allocated to either the test group, with daily intake of a single capsule containing 194 mg of MAEC for eight weeks, or control group, with placebo. Clinical periodontal evaluation and immunological parameters from saliva and gingival sulcular fluid were assessed at baseline, four, and eight weeks. Individual PROMs were assessed by OHIP-14 questionnaires. Results: There was a significant difference of modified gingival index at four and eight weeks between the test and control groups. In the test group, crevicular interleukin (IL)-6 was reduced, and the salivary matrix metalloproteinase (MMP)-9 was increased after eight weeks. PROMs were improved up to four weeks compared to placebo. Conclusion: Oral administration of MAEC would have a potential to reduce gingival inflammation clinically and immunologically in the patients with gingivitis and incipient periodontitis.

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