The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient

NCT02202304 | Withdrawn Phase 4 DMC

• 1 other identifier: CHLOVADENT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.
3. 3.Bleeding on probing (BoP).
4. 4.Plaque formation.
5. 5.Periodontal pocket depths.
6. 6.Microbial composition and GCF cytokine profile of the sub gingival environment.
7. 7.The patients self perception of oral health.

Conditions

Periodontal Disease; Caries

Outcome Measures

Primary Outcomes (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

  we will measure the Loss of Attachment (LoA) around each abutment tooth at 6 points

  Assesed at the begining, at 12 months and at 24 months

Secondary Outcomes (1)

• 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

  at the beginning, at 12 months and at 24 months

Study Arms (2)

Chlorhexidine/Thymol varnish

EXPERIMENTAL

Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush by "painting" it over the surfaces of these teeth.

Drug: Chlorhexidine/Thymol varnish

Placebo varnish

PLACEBO COMPARATOR

Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush and "painting" it on all the surfaces of these teeth..

Drug: Chlorhexidine/Thymol varnish

Interventions

Chlorhexidine/Thymol varnish DRUG

This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.

Also known as: Cervitec Plus (1% chlorhexidine plus 1% thymol)

Chlorhexidine/Thymol varnish; Placebo varnish

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that are going to have a new denture fitted at the Dental School of the University of Aberdeen and Penninsula Dental School.
• Patients aged 18 years or over.

You may not qualify if:

• Patients that already have a denture.
• Patients that are taking antibiotics.
• Patients allergic to any of the components of the products.
• Pregnant women.
• Severe systemic illness.
• Patient with active periodontal disease (BoP and pockets ≥3mm) on abutment teeth.
• Presence of caries on abutment teeth.

Sponsors & Collaborators

• Rosa Moreno Lopez: lead
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, Aberdeenshire, AB252ZR, United Kingdom

Location

Related Publications (4)

• Baca P, Clavero J, Baca AP, Gonzalez-Rodriguez MP, Bravo M, Valderrama MJ. Effect of chlorhexidine-thymol varnish on root caries in a geriatric population: a randomized double-blind clinical trial. J Dent. 2009 Sep;37(9):679-85. doi: 10.1016/j.jdent.2009.05.001. Epub 2009 May 13.

  PMID: 19497653 BACKGROUND

• Tanaka J, Tanaka M, Kawazoe T. Longitudinal research on the oral environment of elderly wearing fixed or removable prostheses. J Prosthodont Res. 2009 Apr;53(2):83-8. doi: 10.1016/j.jpor.2008.10.003. Epub 2009 Jan 10.

  PMID: 19318078 BACKGROUND

• Shimura Y, Wadachi J, Nakamura T, Mizutani H, Igarashi Y. Influence of removable partial dentures on the formation of dental plaque on abutment teeth. J Prosthodont Res. 2010 Jan;54(1):29-35. doi: 10.1016/j.jpor.2009.08.003. Epub 2009 Oct 8.

  PMID: 19818702 BACKGROUND

• Clavero J, Baca P, Paloma Gonzalez M, Valderrama MJ. Efficacy of chlorhexidine-thymol varnish (Cervitec) against plaque accumulation and gingival inflammation in a geriatric population. Gerodontology. 2006 Mar;23(1):43-7. doi: 10.1111/j.1741-2358.2006.00085.x.

  PMID: 16433641 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Chlorhexidine; chlorhexidine, thymol drug combination; Thymol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes

Study Officials

• Rosa Moreno Lopez, BDS

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 29, 2014
• Study Start: September 10, 2017
• Primary Completion: September 10, 2019
• Study Completion: December 10, 2020
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)