NCT02493803

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 16, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

May 18, 2015

Last Update Submit

September 15, 2016

Conditions

Erosive Tooth Wear

Outcome Measures

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

    6 months

Study Arms (2)

Receive detailed dietary advice

EXPERIMENTAL

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

Behavioral: Dietary Advice

Receive standard of care dietary advice

NO INTERVENTION

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

Interventions

Dietary AdviceBEHAVIORAL

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

Receive detailed dietary advice

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Institute, Guy's Hospital

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

July 10, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-02

Locations

GB(1)