Periodontal DiseasePhase 4NCT02202304
The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient
A Phase 4 study testing Chlorhexidine/Thymol varnish in people with Periodontal Disease and Caries, run by Rosa Moreno Lopez at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Caries
- What is being tested?
- Chlorhexidine/Thymol varnish
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2017to 10 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen
Aberdeen, Aberdeenshire, AB252ZR
About this study
Official title: The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.
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:
Read more
- 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
- 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:
- 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:
- Bleeding on probing (BoP).
- Plaque formation.
- Periodontal pocket depths.
- Microbial composition and GCF cytokine profile of the sub gingival environment.
- The patients self perception of oral health.
Read the 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).
- Conditions
- Periodontal Disease, Caries
- Being tested
- Chlorhexidine/Thymol varnish
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine/Thymol varnishDrug
Also called Cervitec Plus (1% chlorhexidine plus 1% thymol)
This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.. Receives: Drug: Chlorhexidine/Thymol varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
We will record the presence of dental caries using ICDAS
Measured: at the beginning, at 12 months and at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study start10 Sep 2017 (estimated)
- Primary completion10 Sep 2019 (estimated)
- Study completion10 Dec 2020 (estimated)
Why it stopped: Researcher changed jobs. Unable to carry out the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosa Moreno Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Sponsor-investigator, Rosa Moreno Lopez, University of Aberdeen
- Investigators
- Rosa Moreno Lopez, BDS, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202304
- Sponsor's protocol ID
- CHLOVADENT
- Status last verified
- May 2017
- First submitted
- 24 Jul 2014
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: within 6 months
Publications
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.
PubMed 19497653Tanaka 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.
PubMed 19318078Shimura 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.
PubMed 19818702Clavero 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.
PubMed 16433641
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.
- ClinicalTrials.gov ID
- NCT02202304
- Acronym / sponsor ID
- CHLOVADENT
- Conditions
- Periodontal Disease, Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researcher changed jobs. Unable to carry out the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rosa Moreno LopezUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- 10 Sep 2017 (estimated)
- Primary completion
- 10 Sep 2019 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- 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:
- Bleeding on probing (BoP).
- Plaque formation.
- Periodontal pocket depths.
- Microbial composition and GCF cytokine profile of the sub gingival environment.
- The patients self perception of oral health.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine/Thymol varnish | Experimental | Drug: Chlorhexidine/Thymol varnishParticipants 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. |
| Placebo varnish | Placebo comparator | Drug: Chlorhexidine/Thymol varnishParticipants 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.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine/Thymol varnishAlso: Cervitec Plus (1% chlorhexidine plus 1% thymol)This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years. | Drug | Chlorhexidine/Thymol varnish, Placebo varnish |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Background: PubMed 19497653Baca 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.
- Background: PubMed 19318078Tanaka 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.
- Background: PubMed 19818702Shimura 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.
- Background: PubMed 16433641Clavero 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.
- Individual participant dataSharing planned: Yes. within 6 months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Moreno Lopez, BDS principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine/Thymol varnish in people with Periodontal Disease and Caries, run by Rosa Moreno Lopez at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202304, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.