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Trial record 2 of 11 for:    thymol

The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient

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ClinicalTrials.gov Identifier: NCT02202304
Recruitment Status : Withdrawn (Researcher changed jobs. Unable to carry out the project)
First Posted : July 29, 2014
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Rosa Moreno Lopez, University of Aberdeen

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. 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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Caries Drug: Chlorhexidine/Thymol varnish Phase 4

Detailed Description:
  • 2 baseline samples of the Gingival Crevicular Fluid (GCF) and the subgingival samples. The first baseline sample will be done on the day of the first impressions and the second one the day of denture fitting.
  • The following information will be recorded on the CRFs: Silness and Löe Plaque index, BoP, probing depth, clinical attachment level, LoA, Kennedy classification, material of the partial denture and type of clasp (or no clasp) and ICDAS code.
  • The patient will also fill in the OHIP-14 questionnaire (Oral Health Impact Profile) to assess their self perception of oral health.
  • A photograph of the abutment teeth and the partial denture will be taken.
  • We will also take a full history of the patient including: name, DOB and medications.
  • The GCF and subgingival sampled will be taken every 6 months on the appointment where the varnish is applied.
  • All the laboratory samples will be labelles with the same identification number that the patient has been allocated and a date will also be written on it. All the samples will be analysed in Plymouth and stored in a - 50°C freezer (the samples taken at the University of Aberdeen will be stored in the same type of freezer and shipped periodically to the Penninsula University for tests maintaining the same temperature conditions). They will be testing the microbial composition and GCF cytokine profile of the sub gingival environment
  • All measurements will be reassessed at 12 months and 24 months. In addition to the denture hygiene index: Budtz-Jørgensen (1977) Index (plaque accumulation on the denture).

The data will be collected by one clinician in each dental school. All clinicians will be calibrated appropriately.

Calibration: Before any examination starts we will assess the consistency of each examiner (intra-exmainer) and also the variation between exmainers (inter-exmainer reproducibility). Each examiner will independently examiner the same group of 20 subjects and compare his or her findings. When findings contain major discrepancies, subjects should be recalled in order that differences in diagnoses can be reviewed by the exmainers and resolved by group discussion. If certain examiners consistently produce significantly different results from the majority, and attmepts to correct their performance fail, they will be excluded from the team. It will be made clear to all potential examiners, before these exmainations begin, that ability to standardize examination results is not a measure of clinical skills (Oral Health Surveys 4th edition. WHO. Geneva 1997) All the data will be recorded on the case report forms (CRFs).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.
Estimated Study Start Date : September 10, 2017
Estimated Primary Completion Date : September 10, 2019
Estimated Study Completion Date : December 10, 2020


Arm Intervention/treatment
Experimental: Chlorhexidine/Thymol varnish
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
This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.
Other Name: Cervitec Plus (1% chlorhexidine plus 1% thymol)

Placebo Comparator: Placebo varnish
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
This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.
Other Name: Cervitec Plus (1% chlorhexidine plus 1% thymol)




Primary Outcome Measures :
  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 [ Time Frame: Assesed at the begining, at 12 months and at 24 months ]
    we will measure the Loss of Attachment (LoA) around each abutment tooth at 6 points


Secondary Outcome Measures :
  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 [ Time Frame: at the beginning, at 12 months and at 24 months ]
    We will record the presence of dental caries using ICDAS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202304


Locations
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United Kingdom
University of Aberdeen
Aberdeen, Aberdeenshire, United Kingdom, AB252ZR
Sponsors and Collaborators
Rosa Moreno Lopez
Ivoclar Vivadent AG
Investigators
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Principal Investigator: Rosa Moreno Lopez, BDS University of Aberdeen

Publications:
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Responsible Party: Rosa Moreno Lopez, Dr, University of Aberdeen
ClinicalTrials.gov Identifier: NCT02202304     History of Changes
Other Study ID Numbers: CHLOVADENT
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: within 6 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thymol
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Antifungal Agents