Clinical Trial: Treatment of Root Caries in an Older Irish Population.
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Randomised Controlled Clinical Trial to Compare Restorative Materials in the Treatment of Root Caries in an Older Irish Population.
Brief Summary:
This study will involve filling teeth which have decay on their roots with three different filling materials. Patients will attend Cork University Dental School and hospital for a clinical examination and to complete a questionnaire describing how they feel about the comfort and appearance of their teeth. Patients will be asked to provide a sample of saliva by spitting into a tube. This saliva will be tested to see what levels of bacteria are present and how well their saliva neutralises acid in their diet. This is used to assess how high or low the patient's risk of dental decay is. They will also complete a questionnaire about the amount of sugar in their diet and how often they clean their teeth. If the exam shows that any teeth are so decayed that they cannot be filled, the patient will then be offered extraction of these teeth. All treatment will be discussed with the patient. Patients will be randomly assigned one of the three materials and this material will be used for their fillings. Patients will not know which of the three materials they received but all three materials are already in use in dentistry and all of the elements of each treatment plan are well recognised, routine dental procedures. After all the treatment has been completed, each patient will be shown how best to take care of their teeth and how to manage their sugar intake to reduce their risk of further decay.
Patients will be given appointments to return for review at 6 months, 12 months, 18 months and 24 months after treatment. This will include a dental examination and dental impressions will be taken. These are used to measure how the restorative materials wear over time. Patients will also be asked to complete again the two questionnaires that they completed at their first visit to see if any of their answers have changed.
Detailed Summary:
Randomized Clinical Trial This study is a prospective study of older adults. It will assess the suitability of BiodentineTM as a filling material for Class V lesions and compare it's performance to that of Glass ionomer cement (GIC) and Resin-modified glass ionomer cement (RMGIC).
Patients for the study will attend Cork University Dental School and Hospital. These patients will represent a sample of the population of elderly who are generally well and able to care for themselves independently as well as adhere to a given maintenance programme. The general methods are outlined below.
Ethical Approval Ethical approval has been obtained from the Research Ethics Committee of the Cork Teaching Hospitals (CREC) for the recruitment, sampling, and treatment of elderly patients. Written informed consent will be obtained from all participants.
Inclusion Criteria
For inclusion in this research patients will:
- Be either male or female aged 65 or over
- Present a minimum of 6 teeth in one arch
- Have sufficient manual dexterity to undertake tooth-brushing
- Have sufficient cognitive ability to understand consent procedures and be able to complete a questionnaire
Exclusion Criteria
Patients will not be eligible for inclusion if:
- They are medically frail (ASA III or IV)
- They have pulpal involvement or painful symptomology other than sensitivit
Sponsor: University College Cork
Current Primary Outcome: Survival of restorations [ Time Frame: 2 year follow up ]
Restorations will be assessed by a blinded examiner to determine whether they are still in situ or whether they have been lost.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University College Cork
Dates:
Date Received: May 28, 2013
Date Started: July 2012
Date Completion: December 2018
Last Updated: May 10, 2016
Last Verified: May 2016
