Impact of Dietary Advice on the Progression of Tooth Wear

NCT ID: NCT02493803

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-08-31

Brief Summary

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

Detailed Description

A sample size of 60 patients will be recruited separately from an epidemiology study and written informed consent will be obtained. Patients presenting with moderate to severe tooth wear will be recruited. Those with a Basic Erosive Wear Examination (BEWE) cumulative score greater than or equal to 8 but with at least one score of 3 on the occlusal surfaces of the lower molars or the incisal edge of the upper central incisor. After randomisation, an impression will be taken of the upper and lower teeth using a silicone material. One group will receive one-to-one dietary advice (with dietary information sheets) as the intervention and the other group will not receive any intervention. The silicone impressions will be repeated 6 months later. Impressions will be cast in stone and the occlusal surfaces of the upper or lower molars and the buccal surface of the upper central and lateral incisors will be scanned to monitor tooth wear progression. The two scans of the involved teeth will be superimposed and the level of tooth wear over that time will be calculated.

The investigators aim to see if giving detailed dietary advice will result in less erosive tooth wear.

Conditions

Erosive Tooth Wear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Receive detailed dietary advice

Half of the participants will be randomly allocated to receive detailed dietary advice

Group Type: EXPERIMENTAL

Dietary Advice

Intervention Type: BEHAVIORAL

Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist

Receive standard of care dietary advice

These patients will receive dietary advice which is the current standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary Advice

Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dental Institute, Guy's Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

RJ114/N306

Identifier Type: -

Identifier Source: org_study_id