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At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
0.12 % chlorhexidine + 0.2 % NaF mouthrinse +3 moredrug
Likely dose
0.12 % chlorhexidine + 0.2 % NaF mouthrinse 10 mlfrom record
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Search/NCT02935322
NCT02935322Phase 4Completed
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Interaction Chlorhexidine-fluoride - a 4-day and 6-week Randomised Clinical Mouthrinse Study

University of Oslo·interventional·Posted Oct 17, 2016·Updated Oct 17, 2016

In Brief

A Phase 4 clinical trial evaluating 0.12 % chlorhexidine + 0.2 % NaF mouthrinse, 0.2 % NaF mouthrinse, and 2 other interventions for Periodontal Disease and Dental Caries. Completed, enrolled 32 participants.

Detailed Summary

The aim of the present study was to study if there are interactions and reduced clinical effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodontal Disease, Dental Caries
Countries--
CollaboratorsGöteborg University

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2016
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.7 years ago

Interventions

0.12 % chlorhexidine + 0.2 % NaF mouthrinsedrug

In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period.

0.2 % NaF mouthrinsedrug

In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period.

0.12% chlorhexidinedrug

In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period.

Placeboother

Contained all basic ingredients as the other three mouthrinses but no chlorhexidine and no NaF. In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned solution twice daily after tooth brushing during a 6-week period.