Back to resultsImpact of Dietary Advice on the Progression of Tooth Wear (DAI)
Primary Purpose
Erosive Tooth Wear
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietary Advice
Sponsored by
About this trial
This is an interventional prevention trial for Erosive Tooth Wear
Eligibility Criteria
Inclusion Criteria:
- 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.
- This wear will be as a result of a high acid diet i.e. as at least two dietary acidic challenges a day.
- Adult 25-70 years old.
- 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
- No anterior crowns/ bridges or implants opposing the lower molars or upper incisors
- Written consent to the study
Exclusion Criteria:
- Pregnancy or breast feeding
- Medical history likely to impact on attendance or mobility
- Presence of periodontal disease or caries on more than one tooth. BPE score of 2 or above.
- Unable to speak or understand English
- Saliva diagnoses (xerostomia- dry mouth)
- Orthodontic appliances
- Severe dentine hypersensitivity
- Restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars.
- 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.
Sites / Locations
- Dental Institute, Guy's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Receive detailed dietary advice
Receive standard of care dietary advice
Arm Description
Half of the participants will be randomly allocated to receive detailed dietary advice
These patients will receive dietary advice which is the current standard of care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02493803
First Posted
May 18, 2015
Last Updated
September 15, 2016
Sponsor
King's College London
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT02493803
Brief Title
Impact of Dietary Advice on the Progression of Tooth Wear
Acronym
DAI
Official Title
Impact of Dietary Advice on the Progression of Tooth Wear
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Tooth Wear
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receive detailed dietary advice
Arm Type
Experimental
Arm Description
Half of the participants will be randomly allocated to receive detailed dietary advice
Arm Title
Receive standard of care dietary advice
Arm Type
No Intervention
Arm Description
These patients will receive dietary advice which is the current standard of care
Intervention Type
Behavioral
Intervention Name(s)
Dietary Advice
Intervention Description
Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist
Primary Outcome Measure Information:
Title
Loss of tooth height
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
This wear will be as a result of a high acid diet i.e. as at least two dietary acidic challenges a day.
Adult 25-70 years old.
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
No anterior crowns/ bridges or implants opposing the lower molars or upper incisors
Written consent to the study
Exclusion Criteria:
Pregnancy or breast feeding
Medical history likely to impact on attendance or mobility
Presence of periodontal disease or caries on more than one tooth. BPE score of 2 or above.
Unable to speak or understand English
Saliva diagnoses (xerostomia- dry mouth)
Orthodontic appliances
Severe dentine hypersensitivity
Restoration of the occlusal or incisal surfaces of upper anterior teeth and first molars.
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.
Facility Information:
Facility Name
Dental Institute, Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
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Impact of Dietary Advice on the Progression of Tooth Wear
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