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NCT02202304

The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient

Withdrawn Phase 4 Last updated 15 May 2017
What this trial tests

Phase 4 trial testing Chlorhexidine/Thymol varnish in Periodontal Disease. Withdrawn.

Timeline
10 September 2017
Primary endpoint
10 September 2019
10 December 2020

Quick facts

Lead sponsorRosa Moreno Lopez
PhasePhase 4
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Start date10 September 2017
Primary completion10 September 2019
Estimated completion10 December 2020
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Rosa Moreno Lopez — full company profile →

Who can join

18 and older, any sex, with Periodontal Disease or Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger populations. This study wants to investigate if the use of this product would reduce the risk of losing abutment teeth on patients that are wearing partial dentures as the literature has proven that these teeth are more prone to caries and periodontal disease. The primary objectives of this research project are to: 1. Assess if the topical application of CHX/thymol varnish every three months on partial denture abutment teeth results in a clinicallu significant decrease in any loss of attachment compared to no application, and 2. Assess if the topical application of CHX/thymol vanirhs every three months on partial denture abutment teeth results in a clinically significant decrease in carious lesion development or progression compared to no application. The secondary objectives of this research project are to: 1\. Assess of the topical application of CHX/thymol varnish every three months on partial denture abutment teeth compared to no application results in a clinically significant difference in: 1. Bleeding on probing (BoP). 2. Plaque formation. 3. Periodontal pocket depths. 4. Microbial composition and GCF cytokine profile of the sub gingival environment. 5. The patients self perception of oral health.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing