scholarly journals Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.

2020 ◽  
Author(s):  
Charles Richard Parkinson ◽  
Kimberly R MILLEMAN ◽  
Jeffery L MILLEMAN
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Negative Control ◽  
Periodontal Health ◽  
Stannous Fluoride ◽  
Dental Prophylaxis ◽  
Parallel Group ◽  
Fluoride Dentifrice ◽  
Adult Volunteers

Abstract Background: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis, proportion of subjects moving between gingivitis severity (<10%, >10%<30%, >30% bleeding sites) and oral hygiene, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. Method: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00/High >2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 hrs prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. Results: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p<0.0001). At 24, 71% of subjects in the 0.453% SnF 2 treatment group demonstrated <10% of bleeding sites. Conclusion: A dentifrice containing 0.454% w/w SnF 2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF 2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” (<10%) following a dental prophylaxis and 24 weeks of product use.

scholarly journals Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.

2020 ◽  
Author(s):  
Charles Richard Parkinson ◽  
Kimberly R MILLEMAN ◽  
Jeffery L MILLEMAN
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Negative Control ◽  
Periodontal Health ◽  
Stannous Fluoride ◽  
Dental Prophylaxis ◽  
Parallel Group ◽  
Fluoride Dentifrice ◽  
Adult Volunteers

Abstract Background: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (<10%, >10%<30%, >30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. Method: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High >2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 hrs prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. Results: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p<0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated <10% bleeding sites. Conclusion: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” (<10%) following a dental prophylaxis and 24 weeks of product use.

scholarly journals Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.

2019 ◽  
Author(s):  
Charles Richard Parkinson ◽  
Kimberly R MILLEMAN ◽  
Jeffery L MILLEMAN
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Negative Control ◽  
Stannous Fluoride ◽  
Dental Prophylaxis ◽  
Parallel Group ◽  
Fluoride Dentifrice ◽  
Adult Volunteers ◽  
Dental Plaque Index

Abstract Background: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis, as measured by a modified gingival index (MGI), a bleeding index (BI), and oral hygiene, as assessed by a dental plaque index (PI), following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks.Method: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI, BI and PI assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High >2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 hrs prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores.Results: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p<0.0001). At 24, 71% of subjects in the 0.453% SnF2 treatment group demonstrated <10% of bleeding sites.Conclusion: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” following a dental prophylaxis and 24 weeks of product use.

scholarly journals A single-centre investigator-blinded randomised parallel group clinical trial to investigate the effect of probiotic strainsStreptococcus salivariusM18 andLactobacillus acidophiluson gingival health of paediatric patients undergoing treatment with fixed orthodontic appliances: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030638 ◽  
Author(s):  
Eleftherios G Kaklamanos ◽  
Rania Nassar ◽  
Sotirios Kalfas ◽  
Manal Al Halabi ◽  
Mawlood Kowash ◽  
...  
Keyword(s):  
Treatment Group ◽  
Oral Hygiene ◽  
Oral Microbiome ◽  
Control Group ◽  
Orthodontic Appliances ◽  
Single Centre ◽  
Paediatric Patients ◽  
Gingival Health ◽  
Parallel Group ◽  
Fixed Orthodontic Appliances

BackgroundThere is limited data on the beneficial effects of probiotics on the gingival health of patients undergoing treatment with fixed orthodontic appliances. This study aims to compare the effect of probiotic tablets combined with regular oral hygiene versus regular oral hygiene alone on gingival status in these patients. The effect of probiotic intake on plaque formation and salivary microbiome composition will be also assessed.Methods and analysisThis is a 3 month single-centre, single blind (clinical and laboratory examiners), parallel group randomised controlled two arm superiority trial. Fifty paediatric patients attending the Postgraduate Orthodontic Clinic at the Hamdan Bin Mohammed College of Dental Medicine (HBMCDM), Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai, United Arab Emirates, who meet the eligibility criteria will be recruited. Block randomisation with 1:1 allocation and concealment of allocation will be carried out. The treatment group will receive probiotic tablets containingStreptococcus salivariusM18 andLactobacillus acidophilustogether with regular oral hygiene versus the control group on regular oral hygiene alone. Clinical examination and collection of saliva for microbiome assay will be carried out at baseline and end of study. Self-reporting by patients will be used to document acceptability and adverse effects. Statistically significant decrease in gingival bleeding on probing in the treatment group will be classified as primary outcome of treatment success. Statistically significant reduction in Plaque Index, Gingival Index and shift in the composition of the oral microbiome in favour of beneficial bacteria are secondary outcomes indicative of efficacy of probiotic intake.Ethics and disseminationEthical approval for the study has been granted by the HBMCDM, MBRU, Institutional Review Board (Reference #: MBRU-IRB-2018–015). Study findings will be disseminated via publication in peer-reviewed journal.Trial registration numberISRCTN95085398

scholarly journals Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Pei Liu ◽  
Weiye Wen ◽  
Ka Fung Yu ◽  
Xiaoli Gao ◽  
Edward Chin Man Lo ◽  
...  
Keyword(s):  
Oral Health ◽  
Pregnant Women ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Oral Health Promotion ◽  
Periodontal Health ◽  
The Mean ◽  
Family Centered

Abstract Background Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum. Methods A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T0), in the 32nd gestational week (T1), and 12 months postpartum (T2). Results Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T0 was 0.19, which decreased to 0.14 at T1 and 0.15 at T2. In the control group, the mean VPI decreased from 0.19 at T0 to 0.16 at T1, but increased to 0.22 at T2. A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T1 and T2. The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T0:57%, T1:46%, T2:35%) than in the control group (T0:58%, T1:52%, T2:46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001). Conclusions Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone. Trial registration Clinicaltrials.gov, #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1

An Anticalculus Dentifrice with Sodium Hexametaphosphate and Stannous Fluoride: A Six-month Study of Efficacy

2007 ◽  
Vol 8 (5) ◽  
pp. 1-8 ◽  
Author(s):  
J. Leslie Winston ◽  
Thomas Schiff ◽  
Susan K. Fiedler ◽  
Robert A. Baker
Keyword(s):  
Soft Tissue ◽  
Home Care ◽  
Clinical Significance ◽  
Negative Control ◽  
Sodium Hexametaphosphate ◽  
Control Group ◽  
Stannous Fluoride ◽  
Parallel Group ◽  
Calculus Formation ◽  
Oral Soft Tissue

Abstract Aim To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/ sodium hexametaphosphate) with a negative control. Methods and Materials This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. Results Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. Conclusion The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. Clinical Significance The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care. Citation Winston JL, Fiedler SK, Schiff T, Baker RA. An Anticalculus Dentifrice with Sodium Hexametaphosphate and Stannous Fluoride: A Six-month Study of Efficacy. J Contemp Dent Pract 2007 July;(8)5:001-008.

A Clinical Assessment of the Efficacy of a Stannous-Containing Sodium Fluoride Dentifrice on Dentinal Hypersensitivity

2010 ◽  
Vol 11 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Tao He ◽  
Trevor Day ◽  
Johannes Einwag ◽  
Joachim S. Hermann ◽  
Mary Kay Anastasia ◽  
...  
Keyword(s):  
Sodium Fluoride ◽  
Clinical Assessment ◽  
Negative Control ◽  
Control Group ◽  
Lower Sensitivity ◽  
Double Blind ◽  
Parallel Group ◽  
Sensitive Teeth ◽  
Fluoride Dentifrice ◽  
Dentinal Hypersensitivity

Abstract Aim To measure the desensitizing benefits of an experimental stannous-containing sodium fluoride dentifrice versus a regular sodium fluoride negative control. Methods and Materials This study was a randomized, double-blind, parallel group, fourweek clinical trial. Subjects reporting dentinal hypersensitivity were enrolled and randomized to the experimental dentifrice or the control dentifrice to use twice daily for four weeks. Efficacy assessments (Air Blast) were performed at baseline and weeks two and four. Separate analyses were performed for the two most sensitive teeth at baseline and for all 12 teeth. Results for weeks two and four combined also were analyzed. Results Thirty-one subjects were included in the analyses. For the two most sensitive teeth, the experimental dentifrice showed statistically significantly less sensitivity (p<0.05) versus the control at weeks two and four and for weeks two and four combined. The sensitivity reduction ranged from 24.9% to 28.4% over the control. For all 12 teeth, the experimental group had statistically significantly (p<0.03) lower sensitivity scores versus the control group at week two and weeks two and four combined. Conclusion The experimental dentifrice demonstrated significant desensitizing advantages versus the control. Clinical Significance This stannouscontaining sodium fluoride dentifrice provides an effective treatment for patients with dentinal hypersensitivity, significantly reducing sensitivity versus a negative control in this four-week trial. Citation Day TN, Einwag J, Hermann JS, He T, Anastasia MK, Barker M, Zhang Y. A Clinical Assessment of the Efficacy of a Stannous- Containing Sodium Fluoride Dentifrice on Dentinal Hypersensitivity. J Contemp Dent Pract [Internet]. 2010 Jan; 11(1):001-008. Available from:http://www.thejcdp.com/journal/view/volume11- issue1-day.

scholarly journals Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial

2020 ◽  
Author(s):  
Pei Liu ◽  
Weiye Wen ◽  
Ka Fung Yu ◽  
Xiaoli Gao ◽  
Edward Chin Man Lo ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Periodontal Health ◽  
Oral Health Education ◽  
Randomized Controlled ◽  
Gestational Week ◽  
Family Centered

Abstract Objectives: Poor oral hygiene and higher hormone levels during pregnancy always lead to poor periodontal health. Oral health education of the pregnant women to improve the periodontal outcomes might be ineffective and inconsistent. The aim of this study was to assess the effectiveness of a family-centered behavioral and educational counselling program on the pregnant women’s periodontal health and long-term effect after delivery. Methods: A randomized controlled trial was conducted among first-time pregnant women (10~20th gestational-week) in Hong Kong. Participating families were randomized into test and control group. The intervention in test group included: explanation on oral health education pamphlets, oral hygiene practice training by the “tell-show-do” technique, individualized feedback, and proposed solutions to overcome barriers on self-care. Reinforcement was implemented by interview, phone call or messaging to assess performance, identify barriers and to encourage participants on self-care, in around 32nd gestational-week and 6 months after delivery. Main outcomes assessed were periodontal health measurement including bleeding on probing (BOP), periodontal-pocket (Poc) and loss of clinical attachment levels (LoA); oral hygiene status was assessed by visible plaque index (VPI). The dental examinations were carried out at baseline, 32nd gestational-week and 12-months post-delivery.Results: 589 pregnant women were recruited and 369 completed all three visits (test 188; control 181). Mixed-effect model ANOVA indicated that in test group, % sites with visible plaque decreased from the baseline to the 32nd gestational-week and maintained to 12-months post-delivery while in control group the effect could not be sustained (p<0.001). Both groups showed significant decrease in BOP over time, and significantly lower % sites with BOP was found in test group than in control group at 12-months post-delivery (p<0.001). Generalized linear mixed model (GLMM) showed that there was significant less in sites with Poc and LoA in the both groups over time at 12-months post-delivery than during pregnancy (p<0.001), whereas there was no significant effect between the two groups (p>0.05). Conclusions: Providing family-centered, behavioral and educational counselling to pregnant women at early stage of pregnancy and reinforcements can improve their oral hygiene and periodontal health, the effect can be sustained over a longer period.

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