Treatment of Root Caries in an Older Irish Population.

NCT01866059 | Unknown DMC

• 1 other identifier: Root Caries Cork
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Root Caries; Over Sixty-five Years of Age; >=Two Carious Root Surfaces Per Patient

Keywords

root caries; GIC; RMGIC; Biodentine; Calcium silicate

Outcome Measures

Primary Outcomes (1)

• Survival of restorations

  Restorations will be assessed by a blinded examiner to determine whether they are still in situ or whether they have been lost.

  2 year follow up

Study Arms (3)

Calcium silicate cement

EXPERIMENTAL

Biodentine

Device: Calcium silicate cement

Glass Ionomer Cement

ACTIVE COMPARATOR

Fuji IX

Device: Glass Ionomer Cement

Resin Modified Glass Ionomer Cement

ACTIVE COMPARATOR

Fuji II LC

Device: Resin Modified Glass Ionomer Cement

Interventions

Calcium silicate cement DEVICE

Calcium silicate cement

Also known as: Biodentine

Calcium silicate cement

Glass Ionomer Cement DEVICE

Glass Ionomer Cement

Also known as: Fuji IX

Glass Ionomer Cement

Resin Modified Glass Ionomer Cement DEVICE

Resin Modified Glass Ionomer Cement

Also known as: Fuji II LC

Resin Modified Glass Ionomer Cement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• At least 2 natural teeth with active root caries
• Aged 65 or older

You may not qualify if:

• Unable to give consent
• Edentulous
• No active carious root surfaces

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Dental School and Hospital

Cork, Cork, 0000, Ireland

Location

Related Publications (1)

• Hayes M, da Mata C, Tada S, Cole M, McKenna G, Burke FM, Allen PF. Evaluation of Biodentine in the Restoration of Root Caries: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Apr;1(1):51-58. doi: 10.1177/2380084416628474.

  PMID: 30931695 DERIVED

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Finbarr Allen

  University College Cork

  PRINCIPAL INVESTIGATOR

• Martina Hayes

  University College Cork

  PRINCIPAL INVESTIGATOR

• Frank Burke

  University College Cork

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow in Restorative Dentistry

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

IE (1)