Sealing Proximal Non- and Micro-Cavitated Carious Lesions Using a One-Session Separator Technique: A 2-Year Randomised Clinical Study

The presence of initial caries accounts for the majority of approximal carious lesions in many countries. The aim of this clustered, split-mouth, randomised, controlled clinical trial was to use a metal separator to widen the approximal space in a one-visit session before sealing and to evaluate patient acceptance, together with the efficacy of the proximal sealing in arresting incipient carious lesions after 2 years. A total of 48 patients with a mean age of 41.9 years were selected. They had at least one pair of proximal initial carious lesions, including the distal surface of the canines to the mesial surface of the third molars (bite-wing score D1–D3). The patient’s caries risk at baseline was analyzed using a Cariogram. All surfaces were examined for mutans streptococci (ms) counts. The separator technique made it possible to diagnose whether or not a microcavity was present. After 2 years, 212 surfaces in 45 subjects were examined using the same as baseline standardized digital follow-up radiographs. Two analyses were performed, one sensitive, where a progression or a regression was assessed if one of the examiners made one of those diagnoses, and one conservative, where unchanged. For both analyses, the sealed test surfaces showed a significantly higher regression (67 and 29%) compared to the control group (13 and 2%) <i>p</i> < 0.0001. It did not appear that the baseline variables, such as the caries risk, surface diagnoses, or ms counts, influenced the caries outcome. In the test group, there was no difference in caries progression if there was a microcavity or not. The separation treatment was well accepted by the patients. The method of separation for diagnosis and sealing treatment in a single session appears to be a clinically applicable method for the control of proximal carious lesions.

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Microbiological Evaluation of Ozone on Dentinal Lesions in Young Permanent Molars using the Stepwise Excavation

Journal of Clinical Pediatric Dentistry ◽

10.17796/1053-4628-42.1.3 ◽

2018 ◽

Vol 42 (1) ◽

pp. 11-20 ◽

Cited By ~ 4

Author(s):

Osama Safwat ◽

Mona Elkateb ◽

Karin Dowidar ◽

Hala Abdel Salam ◽

Omar El Meligy

Keyword(s):

Base Material ◽

Test Group ◽

Antimicrobial Effect ◽

Mutans Streptococci ◽

Control Group ◽

Controlled Clinical Trial ◽

Microbial Count ◽

Stepwise Excavation ◽

Permanent Molars ◽

And Control

Aim: To assess the microbial effect of ozone gas on dentinal lesions in young permanent molars using the stepwise excavation. Study design: An experimental, controlled clinical trial was performed. The sample included 80 immature first permanent molars, showing deep occlusal carious cavities that were indicated for stepwise excavation. Following first step of dentin excavation, the sample was divided into test (ozone gas) and control (calcium hydroxide (Ca(OH)2) base material) groups. One half of the cases in each group were evaluated for microbiological changes after 6 months, and the other half after 12 months. Results: Mutans streptococci (MS), Lactobacilli, and Candida counts were significantly reduced immediately after ozone application in the test group (P ≤0.05). At the final assessment period, MS and Lactobacilli were significantly reduced in the test group (P ≤0.05). Meanwhile, the Candida counts were significantly reduced only in the test group of the 6 and 12 month-cases (P ≤0.05). Regarding the control group, the significant reduction in microbial count was observed with MS after 6 and 12 months (P ≤0.05). No significant differences were observed between test and control groups at different evaluation periods (P >0.05). Conclusions: Ozone gas had a significant antimicrobial effect in deep class I carious lesions.

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The control of pain due to dentin hypersensitivity in individuals with molar–incisor hypomineralisation: a protocol for a randomised controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-044653 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044653

Author(s):

Ana Paula Taboada Sobral ◽

Elaine Marcilio Santos ◽

Ana Cecilia Aranha ◽

Paulo Vinícius Soares ◽

Caroline Moraes Moriyama ◽

...

Keyword(s):

Clinical Trial ◽

Tooth Enamel ◽

Control Group ◽

Controlled Clinical Trial ◽

Dentin Hypersensitivity ◽

Molar Incisor Hypomineralisation ◽

Randomised Controlled Clinical Trial ◽

Sensitive Teeth ◽

Randomised Controlled ◽

Incisor Hypomineralisation

IntroductionDentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar–incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.Methods and analysisOne hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.Ethics and disseminationThis protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT04407702.

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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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Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care

BMC Oral Health ◽

10.1186/s12903-021-01637-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jan E. Clarkson ◽

Craig R. Ramsay ◽

David Ricketts ◽

Avijit Banerjee ◽

Chris Deery ◽

...

Keyword(s):

Dental Health ◽

Controlled Clinical Trial ◽

Trial Registry ◽

Posterior Teeth ◽

Carious Lesions ◽

Randomised Controlled Clinical Trial ◽

Deep Carious Lesions ◽

Caries Removal ◽

Randomised Controlled ◽

Selective Caries Removal

Abstract Background Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth. Method This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes. Discussion SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN. Trial registration number: ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search.

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Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

Brazilian Dental Journal ◽

10.1590/s0103-64402012000300009 ◽

2012 ◽

Vol 23 (3) ◽

pp. 235-240 ◽

Cited By ~ 4

Author(s):

Fabricio B. Zanatta ◽

Raquel P. Antoniazzi ◽

Tatiana M. P. Pinto ◽

Cassiano K. Rösing

Keyword(s):

Clinical Trial ◽

Test Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Separate Analysis ◽

Randomized Controlled Clinical Trial ◽

Significance Level ◽

Plaque Removal ◽

Randomized Controlled ◽

Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

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Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel

Journal of Dental Research ◽

10.1177/0022034517730531 ◽

2017 ◽

Vol 97 (2) ◽

pp. 148-154 ◽

Cited By ~ 25

Author(s):

M. Alkilzy ◽

A. Tarabaih ◽

R.M. Santamaria ◽

C.H. Splieth

Keyword(s):

Odds Ratio ◽

Test Group ◽

Assessment System ◽

Laser Fluorescence ◽

Fluoride Varnish ◽

Caries Detection ◽

Control Group ◽

Analog Scale ◽

Self Assembling ◽

Carious Lesions

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy. In vitro, self-assembling peptide P11-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P11-4 for treatment of initial caries, a randomized controlled single-blind study was conducted on children aged >5 y with visible active early caries on erupting permanent molars. Subjects were randomized to either the test group (P11-4 + fluoride varnish) or control group (fluoride varnish alone). Caries were assessed at baseline and at 3 and 6 mo posttreatment per laser fluorescence, a visual analog scale, the International Caries Detection and Assessment System, and Nyvad caries activity criteria. Intention-to-treat analyses were performed, and safety and clinical feasibility of the treatment approaches were assessed. Compared with the control group, the test group showed clinically and statistically significant improvement in all outcomes at 3 and 6 mo. The laser fluorescence readings (odds ratio = 3.5, P = 0.015) and visual analog scale scores (odds ratio = 7.9, P < .0001) were significantly lower for the test group, and they showed regression in the International Caries Detection and Assessment System caries index (odds ratio = 5.1, P = 0.018) and conversion from active to inactive lesions according to Nyvad criteria (odds ratio = 12.2, P < 0.0001). No adverse events occurred. The biomimetic mineralization facilitated by P11-4 in combination with fluoride application is a simple, safe, and effective noninvasive treatment for early carious lesions that is superior to the presently used gold standard of fluoride alone. By regenerating enamel tissue and preventing lesion progression, this novel approach could change clinical dental practice from a restorative to a therapeutic approach. This could avoid additional loss of healthy hard tissue during invasive restorative treatments, potentially enabling longer tooth life and thereby lowering long-term health costs ( ClinicalTrials.gov NCT02724592).

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Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial

International Journal of Dentistry ◽

10.1155/2021/8896408 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Muhanad AlHareky ◽

Jehan AlHumaid ◽

Sumit Bedi ◽

Maha El Tantawi ◽

Mazin AlGahtani ◽

...

Keyword(s):

Clinical Trial ◽

Test Group ◽

The United States ◽

Nerve Fibers ◽

T Test ◽

Control Group ◽

Controlled Clinical Trial ◽

Clinical Trial Registry ◽

Dental Anesthesia ◽

Gate Control Theory

Background. The ‘‘gate control’’ theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5–12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8 ml of 2% lidocaine with 1 : 100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child’s pain experience. The parents were requested to evaluate the child’s ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child’s pain as perceived by the external evaluator. T-test or Mann–Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test. Results. The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean = 6.68 (1.09) and 8.42 (0.50); p = 0.001 ) and FLACC scale (mean = 5.92 (1.05) and 8.16 (0.54); p = 0.002 ), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74); p = 0.08 ). Conclusions. Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

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Immediate Loading of Implant-Supported Single Crowns after Conventional and Ultrasonic Implant Site Preparation: A Multicenter Randomized Controlled Clinical Trial

BioMed Research International ◽

10.1155/2018/6817154 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8 ◽

Cited By ~ 11

Author(s):

Claudio Stacchi ◽

Teresa Lombardi ◽

Domenico Baldi ◽

Calogero Bugea ◽

Antonio Rapani ◽

...

Keyword(s):

Survival Rate ◽

Test Group ◽

Site Preparation ◽

Control Group ◽

Controlled Clinical Trial ◽

Marginal Bone Loss ◽

One Year ◽

And Control ◽

Implant Site Preparation ◽

Single Crowns

Aim. To compare implant survival rate and marginal bone loss (MBL) of immediately loaded single implants inserted by using ultrasonic implant site preparation (UISP) (test) and conventional rotary instrumentation (control). Methods. Two single implants were inserted for each patient: after randomization, test site was prepared by using an ultrasonic device (Piezosurgery Touch, Mectron, Italy) and control site was prepared by using the drills of the selected implant system (Premium AZT, Sweden & Martina, Italy), until reaching a final diameter of 3 mm in both groups. Identical implants (3.8x11.5 mm) were inserted in all sites at crestal level. Impressions were taken and screwed resin single crowns with platform-switched provisional abutments were delivered with 48 hours. Periapical radiographs were taken at provisional crown insertion (T0), 6 months (T1) and one year (T2) after prosthetic loading to measure MBL. All data were tested for normality and subsequently analyzed by paired samples t-test and forward multiple linear regression. Results. Forty-eight patients were treated in six centers with the insertion of ninety-six implants (48 test; 48 control). Four implants in four patients failed within the first six months of healing (two in test group; two in control group; no difference between groups). Forty patients (age 60.1±10.7 years; 22 female, 18 male) were included in the final analysis. Mean MBL after six months of loading was 1.39±1.03 mm in the test group and 1.42±1.16 mm in the control group (p>0.05) and after one year was 1.92±1.14 mm and 2.14±1.55 mm in test and control, respectively (p>0.05). Conclusions. No differences in survival rate and MBL were demonstrated between UISP and conventional site preparation with rotary instruments in immediately loaded dental implants: UISP, with its characteristics of enhanced surgical control and safety in proximity of delicate structures, may be used as a reliable alternative to the traditional drilling systems.

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Treatment Success and User-Friendliness of An Electric Toothbrush App: A Pilot Study

Dentistry Journal ◽

10.3390/dj8030097 ◽

2020 ◽

Vol 8 (3) ◽

pp. 97

Author(s):

Viviane Humm ◽

Daniel Wiedemeier ◽

Thomas Attin ◽

Patrick Schmidlin ◽

Stefanie Gartenmann

Keyword(s):

Pilot Study ◽

Treatment Success ◽

Test Group ◽

Plaque Index ◽

Control Group ◽

Controlled Clinical Trial ◽

User Friendliness ◽

Short Period ◽

Electric Toothbrush ◽

And Control

Electronic and mobile health (eHealth/mHealth) are rapidly growing areas in medicine and digital technologies are gaining importance. In dentistry, digitalization is also an emerging topic, whereby more and more applications are being offered. As an example, using real-time feedback, digital application software (an app) was designed to help users brush their teeth more accurately. However, there is no data on the effectiveness and haptic of such apps. Therefore, a single-blinded, randomized controlled clinical trial was designed: twenty volunteers received an electric toothbrush with an associated app to assess whether the app-assisted toothbrushing is better than without. After a short period of familiarization with the electric toothbrush, plaque index (O‘Leary et al. 1972) was recorded and subjects were assigned to the test (with app; n = 10) or the control group (no app; n = 10). At the end of the 2-week pilot study period, plaque was again assessed and participants in the test group completed a questionnaire about the app’s user-friendliness. Statistical analysis revealed no significant differences between the test and control groups. The plaque index improved on average by 8.5% points in the test and 4.7% points in the control group. Fifty percent of the test group participants were of the opinion that they had achieved better cleaning results and would recommend the app to others, although the app contributed only marginally to increased plaque removal. However, such apps may nevertheless be helpful as motivational tools, especially when tracking and monitoring cleaning data. Therefore, more development and research on this topic is indicated.

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Pre-emptive triple analgesia protocol for tonsillectomy pain control in children: double-blind, randomised, controlled, clinical trial

The Journal of Laryngology & Otology ◽

10.1017/s0022215113000364 ◽

2013 ◽

Vol 127 (4) ◽

pp. 383-391 ◽

Cited By ~ 6

Author(s):

A M A El-Fattah ◽

E Ramzy

Keyword(s):

Postoperative Pain ◽

Visual Analogue Scale ◽

Analogue Scale ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Post Surgery ◽

Scale Scores ◽

Randomised Controlled ◽

At Home

AbstractIntroduction:This double-blind, controlled, parallel-group study was designed to determine the efficacy of pre-emptive triple analgesia for paediatric post-tonsillectomy pain management.Materials and methods:One hundred and thirty-five children were randomised into two groups: pre-emptive triple analgesia (n = 55) and control (n = 80). Pain was assessed using a visual analogue scale (in hospital) and the Parent's Postoperative Pain Measure (at home), and scores recorded.Results:Visual analogue scale scores on awakening and for 6 hours post-surgery were significantly better in the study group than the control group (p < 0.05). The Parent's Postoperative Pain Measure scores of control group children were significantly higher within the first 3 post-operative days (p = 0.000), with a greater percentage of children experiencing significant pain and requiring more analgesia.Conclusion:The proposed multimodal, pre-emptive analgesia protocol for paediatric post-tonsillectomy pain results in less post-operative pain, both in hospital or at home.

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