Periodontal Disease Clinical Trial
Official title:
The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.
Verified date | May 2017 |
Source | University of Aberdeen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 10, 2020 |
Est. primary completion date | September 10, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Aberdeen | Aberdeen | Aberdeenshire |
Lead Sponsor | Collaborator |
---|---|
Rosa Moreno Lopez | Ivoclar Vivadent AG |
United Kingdom,
Baca P, Clavero J, Baca AP, González-Rodríguez 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. — View Citation
Clavero J, Baca P, Paloma González 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | We will record the presence of dental caries using ICDAS | at the beginning, at 12 months and at 24 months |
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