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
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
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.
62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.
This study's enrollment of 60 is above the median of 49 across 41 interventional studies indexed under Tooth Wear.
Browse Tooth Wear studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of the participants will be randomly allocated to receive detailed dietary advice
Behavioral: Dietary Advice
These patients will receive dietary advice which is the current standard of care
Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist
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
The record gives a start of Dec 2014, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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