Treatment of Root Caries in an Older Irish Population.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University College Cork
Sponsor:
Information provided by (Responsible Party):
Martina Hayes, University College Cork
ClinicalTrials.gov Identifier:
NCT01866059
First received: May 28, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Clinical Trial to Compare Restorative Materials in the Treatment of Root Caries in an Older Irish Population.

Resource links provided by NLM:


Further study details as provided by University College Cork:

Primary Outcome Measures:
  • Survival of restorations [ Time Frame: 2 year follow up ] [ Designated as safety issue: No ]
    Restorations will be assessed by a blinded examiner to determine whether they are still in situ or whether they have been lost.


Estimated Enrollment: 130
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium silicate cement
Biodentine
Device: Calcium silicate cement
Calcium silicate cement
Other Name: Biodentine
Active Comparator: Glass Ionomer Cement
Fuji IX
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to give consent
  • Edentulous
  • No active carious root surfaces
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866059

Locations
Ireland
Cork University Dental School and Hospital Recruiting
Cork, Ireland, 0000
Contact: Martina Hayes, BDS NUI    00353214545000    martina.hayes@ucc.ie   
Principal Investigator: Martina Hayes, BDS NUI         
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Finbarr Allen University College Cork
Principal Investigator: Martina Hayes University College Cork
Study Chair: Frank Burke University College Cork
  More Information

No publications provided

Responsible Party: Martina Hayes, Clinical Research Fellow in Restorative Dentistry, University College Cork
ClinicalTrials.gov Identifier: NCT01866059     History of Changes
Other Study ID Numbers: Root Caries Cork
Study First Received: May 28, 2013
Last Updated: May 30, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Cork:
root caries
GIC
RMGIC
Biodentine
Calcium silicate

Additional relevant MeSH terms:
Root Caries
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Methamphetamine
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014