Erosive Tooth Wear Clinical Trial
— DAIOfficial title:
Impact of Dietary Advice on the Progression of Tooth Wear
| Verified date | February 2016 |
| Source | King's College London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: National Health Service |
| Study type | Interventional |
The aim of this research is to investigate the impact of dietary advice on the progression of tooth wear over 6 months using a randomised clinical trial design. Participants with severe tooth wear will be recruited. Half of those patients will receive a detailed dietary advice and the other half will be receive standard of care dietary advice. Moulds will be made of their mouths at the original appointment and 6 months later. These moulds will be scanned and superimposed to see if there is any difference in their level of tooth wear
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | August 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 25 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. Severe tooth wear with a BEWE score of 3 on the occlusal surface of the first lower molars or incisal/buccal surface of the upper central incisor. 2. This wear will be as a result of a high acid diet i.e. as at least two dietary acidic challenges a day. 3. Adult 25-70 years old. 4. Minimum of at least 10 occluding tooth pairs (i.e. at least 10 upper teeth which bite against 10 lower teeth) - including the opposing upper molars and lower incisors 5. No anterior crowns/ bridges or implants opposing the lower molars or upper incisors 6. Written consent to the study Exclusion Criteria: 1. Pregnancy or breast feeding 2. Medical history likely to impact on attendance or mobility 3. Presence of periodontal disease or caries on more than one tooth. BPE score of 2 or above. 4. Unable to speak or understand English 5. Saliva diagnoses (xerostomia- dry mouth) 6. Orthodontic appliances 7. Severe dentine hypersensitivity 8. Restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars. 9. Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning or previous use of the weight loss medications. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Dental Institute, Guy's Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| King's College London | Procter and Gamble |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Loss of tooth height | Models of the teeth taken at 6 month epochs will be scanned using a laser profilometer and superimposed to detect accurately the loss of tooth height that has occurred during the study | 6 months | No |