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Treatment of Root Caries in an Older Irish Population.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Martina Hayes, University College Cork

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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.
Study Start Date : July 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Calcium silicate cement
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01866059

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Cork University Dental School and Hospital
Cork, Ireland, 0000
Sponsors and Collaborators
University College Cork
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Principal Investigator: Finbarr Allen University College Cork
Principal Investigator: Martina Hayes University College Cork
Study Chair: Frank Burke University College Cork
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Martina Hayes, Clinical Research Fellow in Restorative Dentistry, University College Cork Identifier: NCT01866059    
Other Study ID Numbers: Root Caries Cork
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Martina Hayes, University College Cork:
root caries
Calcium silicate
Additional relevant MeSH terms:
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Root Caries
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors