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CompletedNCT02493803DAIUpdated Sep 16, 2016

Impact of Dietary Advice on the Progression of Tooth Wear

An interventional study of Dietary Advice in Erosive Tooth Wear, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-16.

Sponsored by King's College London · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Erosive Tooth Wear
03

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Receive detailed dietary advice

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

    Behavioral: Dietary Advice

  • No intervention
    Receive standard of care dietary advice

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

Interventions

  • BehavioralDietary Advice

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

06

Study locations

1 site
  • Dental Institute, Guy's Hospital
    London, SE1 9RT, United Kingdom
07

Registry details

Key details

Study ID
NCT02493803
Lead sponsor
King's College London
Collaborators
Procter and Gamble
Responsible party
Sponsor
First posted
Jul 10, 2015
Start date
Dec 2014
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Sep 16, 2016

Oversight

Data monitoring committee
No
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