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Researcher changed jobs. Unable to carry out the project
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| Name | Class |
|---|---|
| Ivoclar Vivadent AG | INDUSTRY |
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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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine/Thymol varnish | Drug | This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Moreno Lopez, BDS | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aberdeen | Aberdeen | Aberdeenshire | AB252ZR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19497653 | Background | 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. | |
| 19318078 | 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. |
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within 6 months
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| C079161 | chlorhexidine, thymol drug combination |
| D013943 | Thymol |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010636 |
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| 19818702 | 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. |
| 16433641 | 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. |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |