Treatment of Root Caries in an Older Irish Population.
|ClinicalTrials.gov Identifier: NCT01866059|
Recruitment Status : Unknown
Verified May 2016 by Martina Hayes, University College Cork.
Recruitment status was: Active, not recruiting
First Posted : May 31, 2013
Last Update Posted : May 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Active Root Caries Over Sixty-five Years of Age >=Two Carious Root Surfaces Per Patient||Device: Calcium silicate cement Device: Glass Ionomer Cement Device: Resin Modified Glass Ionomer Cement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomised Controlled Clinical Trial to Compare Restorative Materials in the Treatment of Root Caries in an Older Irish Population.|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
Experimental: Calcium silicate cement
Device: Calcium silicate cement
Calcium silicate cement
Other Name: Biodentine
Active Comparator: Glass Ionomer Cement
Device: Glass Ionomer Cement
Glass Ionomer Cement
Other Name: Fuji IX
Active Comparator: Resin Modified Glass Ionomer Cement
Fuji II LC
Device: Resin Modified Glass Ionomer Cement
Resin Modified Glass Ionomer Cement
Other Name: Fuji II LC
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866059
|Cork University Dental School and Hospital|
|Cork, Ireland, 0000|
|Principal Investigator:||Finbarr Allen||University College Cork|
|Principal Investigator:||Martina Hayes||University College Cork|
|Study Chair:||Frank Burke||University College Cork|