T He, Y Zou, J Grender, P Amini, M Kaminski, A R Biesbrock
{"title":"评估氟化亚锡接触频率对牙龈炎影响的随机对照试验。","authors":"T He, Y Zou, J Grender, P Amini, M Kaminski, A R Biesbrock","doi":"10.1177/23800844241263031","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the exposure frequency effect of 0.454% stannous fluoride (SnF<sub>2</sub>) toothpaste in controlling gingivitis.</p><p><strong>Methods: </strong>Two randomized controlled trials enrolled generally healthy adults with gingivitis. The study duration was 1 mo (study 1) and 3 mo (study 2). Gingivitis was assessed using the Löe-Silness Gingival Index (LSGI) at baseline, 1 mo (both studies), and 3 mo (study 2); bleeding scores were derived from the LSGI. Study groups consisted of positive control (twice-daily use of 0.454% SnF<sub>2</sub> toothpaste), experimental group (brushing in the morning with SnF<sub>2</sub> toothpaste and in the evening with 0.76% sodium monofluorophosphate [SMFP] toothpaste), and negative control (twice-daily use of SMFP toothpaste). The primary endpoint was number of bleeding sites.</p><p><strong>Results: </strong>Study 1 and study 2 each enrolled and randomized 90 participants; 86 and 89 participants, respectively, completed the trials. At baseline, the mean (SD) number of bleeding sites was 47.6 (18.54) in study 1 and 41.5 (17.84) in study 2. At 3 mo (study 2), the positive control produced 51.3% fewer bleeding sites, and the experimental group produced 32.5% fewer bleeding sites versus the negative control (<i>P</i> < 0.001 for both). At 1 mo, the positive control produced 45.1% (study 1) and 45.8% (study 2) fewer bleeding sites versus the negative control (<i>P</i> < 0.001 for both), and the experimental group produced 33.0% (study 1) and 24.8% (study 2) fewer bleeding sites, respectively, versus the negative control (<i>P ≤</i> 0.002 for both). The benefit was observed as early as 1 mo and was consistent with 3-mo results.</p><p><strong>Conclusion: </strong>This research is to our knowledge the first to demonstrate a gingivitis-reduction response effect for the frequency of bioavailable SnF<sub>2</sub> toothpaste use, with maximum benefit from twice-daily use, followed by a single-daily exposure versus the negative control. Clinical trial registration numbers: NCT05916508 and NCT05916521.</p><p><strong>Knowledge transfer statement: </strong>The results of this study can be used by dental professionals to guide their recommendations for therapeutic toothpaste for gingival health. Emphasis on the importance of twice-daily brushing with bioavailable stannous fluoride dentifrice will help patients optimize gingival health benefits achieved via self-care.</p>","PeriodicalId":14783,"journal":{"name":"JDR Clinical & Translational Research","volume":null,"pages":null},"PeriodicalIF":2.2000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis.\",\"authors\":\"T He, Y Zou, J Grender, P Amini, M Kaminski, A R Biesbrock\",\"doi\":\"10.1177/23800844241263031\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the exposure frequency effect of 0.454% stannous fluoride (SnF<sub>2</sub>) toothpaste in controlling gingivitis.</p><p><strong>Methods: </strong>Two randomized controlled trials enrolled generally healthy adults with gingivitis. The study duration was 1 mo (study 1) and 3 mo (study 2). Gingivitis was assessed using the Löe-Silness Gingival Index (LSGI) at baseline, 1 mo (both studies), and 3 mo (study 2); bleeding scores were derived from the LSGI. Study groups consisted of positive control (twice-daily use of 0.454% SnF<sub>2</sub> toothpaste), experimental group (brushing in the morning with SnF<sub>2</sub> toothpaste and in the evening with 0.76% sodium monofluorophosphate [SMFP] toothpaste), and negative control (twice-daily use of SMFP toothpaste). The primary endpoint was number of bleeding sites.</p><p><strong>Results: </strong>Study 1 and study 2 each enrolled and randomized 90 participants; 86 and 89 participants, respectively, completed the trials. At baseline, the mean (SD) number of bleeding sites was 47.6 (18.54) in study 1 and 41.5 (17.84) in study 2. At 3 mo (study 2), the positive control produced 51.3% fewer bleeding sites, and the experimental group produced 32.5% fewer bleeding sites versus the negative control (<i>P</i> < 0.001 for both). At 1 mo, the positive control produced 45.1% (study 1) and 45.8% (study 2) fewer bleeding sites versus the negative control (<i>P</i> < 0.001 for both), and the experimental group produced 33.0% (study 1) and 24.8% (study 2) fewer bleeding sites, respectively, versus the negative control (<i>P ≤</i> 0.002 for both). The benefit was observed as early as 1 mo and was consistent with 3-mo results.</p><p><strong>Conclusion: </strong>This research is to our knowledge the first to demonstrate a gingivitis-reduction response effect for the frequency of bioavailable SnF<sub>2</sub> toothpaste use, with maximum benefit from twice-daily use, followed by a single-daily exposure versus the negative control. Clinical trial registration numbers: NCT05916508 and NCT05916521.</p><p><strong>Knowledge transfer statement: </strong>The results of this study can be used by dental professionals to guide their recommendations for therapeutic toothpaste for gingival health. Emphasis on the importance of twice-daily brushing with bioavailable stannous fluoride dentifrice will help patients optimize gingival health benefits achieved via self-care.</p>\",\"PeriodicalId\":14783,\"journal\":{\"name\":\"JDR Clinical & Translational Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-08-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JDR Clinical & Translational Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/23800844241263031\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"DENTISTRY, ORAL SURGERY & MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JDR Clinical & Translational Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/23800844241263031","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}
Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis.
Objective: To evaluate the exposure frequency effect of 0.454% stannous fluoride (SnF2) toothpaste in controlling gingivitis.
Methods: Two randomized controlled trials enrolled generally healthy adults with gingivitis. The study duration was 1 mo (study 1) and 3 mo (study 2). Gingivitis was assessed using the Löe-Silness Gingival Index (LSGI) at baseline, 1 mo (both studies), and 3 mo (study 2); bleeding scores were derived from the LSGI. Study groups consisted of positive control (twice-daily use of 0.454% SnF2 toothpaste), experimental group (brushing in the morning with SnF2 toothpaste and in the evening with 0.76% sodium monofluorophosphate [SMFP] toothpaste), and negative control (twice-daily use of SMFP toothpaste). The primary endpoint was number of bleeding sites.
Results: Study 1 and study 2 each enrolled and randomized 90 participants; 86 and 89 participants, respectively, completed the trials. At baseline, the mean (SD) number of bleeding sites was 47.6 (18.54) in study 1 and 41.5 (17.84) in study 2. At 3 mo (study 2), the positive control produced 51.3% fewer bleeding sites, and the experimental group produced 32.5% fewer bleeding sites versus the negative control (P < 0.001 for both). At 1 mo, the positive control produced 45.1% (study 1) and 45.8% (study 2) fewer bleeding sites versus the negative control (P < 0.001 for both), and the experimental group produced 33.0% (study 1) and 24.8% (study 2) fewer bleeding sites, respectively, versus the negative control (P ≤ 0.002 for both). The benefit was observed as early as 1 mo and was consistent with 3-mo results.
Conclusion: This research is to our knowledge the first to demonstrate a gingivitis-reduction response effect for the frequency of bioavailable SnF2 toothpaste use, with maximum benefit from twice-daily use, followed by a single-daily exposure versus the negative control. Clinical trial registration numbers: NCT05916508 and NCT05916521.
Knowledge transfer statement: The results of this study can be used by dental professionals to guide their recommendations for therapeutic toothpaste for gingival health. Emphasis on the importance of twice-daily brushing with bioavailable stannous fluoride dentifrice will help patients optimize gingival health benefits achieved via self-care.
期刊介绍：
JDR Clinical & Translational Research seeks to publish the highest quality research articles on clinical and translational research including all of the dental specialties and implantology. Examples include behavioral sciences, cariology, oral & pharyngeal cancer, disease diagnostics, evidence based health care delivery, human genetics, health services research, periodontal diseases, oral medicine, radiology, and pathology. The JDR Clinical & Translational Research expands on its research content by including high-impact health care and global oral health policy statements and systematic reviews of clinical concepts affecting clinical practice. Unique to the JDR Clinical & Translational Research are advances in clinical and translational medicine articles created to focus on research with an immediate potential to affect clinical therapy outcomes.
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