CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
0.2% w/v Chlorhexidine digluconate +1 moredrug
Likely dose
0.2% w/v Chlorhexidine digluconate 10 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02319668
NCT02319668Phase 4Completed

A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity

GlaxoSmithKline·interventional·Posted Dec 18, 2014·Updated Jul 19, 2017

In Brief

A Phase 4 clinical trial evaluating 0.2% w/v Chlorhexidine digluconate and Sodium fluoride toothpaste (Aquafresh Mild & Minty) for Dental Prophylaxis and Implant Surgery. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute. Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 18, 2014
Enrollment StartFeb 1, 2015
Primary CompletionJun 1, 2015
Study CompletionFeb 29, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.5 years ago

Interventions

0.2% w/v Chlorhexidine digluconatedrug

Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.

Sodium fluoride toothpaste (Aquafresh Mild & Minty)drug

Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing