Treatment of Root Caries in an Older Irish Population.

May 10, 2016 updated by: Martina Hayes, University College Cork

Randomised Controlled Clinical Trial to Compare Restorative Materials in the Treatment of Root Caries in an Older Irish Population.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 sensitivity
  • They have severe periodontal disease
  • They require antibiotic prophylaxis for invasive dental treatment

Patient Recruitment (Phase 1) Prospective patients will be approached whilst attending Cork University Dental School and Hospital. General medical and dental practitioners in Cork will also be given information regarding the study to distribute to patients that may be suitable. A number of social clubs will also be approached. They will receive all the information in writing including the inclusion criteria as well as a consent form. If they indicate a willingness to participate, they will be offered an examination appointment. Insurance will be provided under the Clinical Indemnity Scheme, University College Cork.

Clinical Examination Procedure The clinical examination procedure will determine the extent of dental disease and confirm the suitability of the patient for enrolment in the study. Clinical data will be collected by a suitably trained examiner. This examiner will also provide the restorative treatment to the patients in the study.

During the course of the initial examination the following data will be collected:

  • Age
  • Gender
  • Number of teeth
  • Visually decayed, missing and filled teeth (VDMFT) index
  • Visually decayed and filled root surfaces (RDFT)
  • Plaque score
  • Bleeding score
  • Community Periodontal Index (CPI)
  • Salivary flow rate
  • Salivary buffer capacity (using CRT®buffer kits)
  • Strep mutans count (using CRT®bacteria kits)
  • Lactobacilli count (using CRT®bacteria kits)
  • Denture wearing (Acrylic/Co-Cr, age of denture, abutment teeth)
  • Fluoride exposure (public/private water supply, toothpaste, mouthwash)
  • Medications (xerostomic potential, sucrose containing)
  • Frequency of sugar intake
  • Dental attendance pattern
  • Alcohol consumption
  • Smoking history
  • Medical History
  • Radiographs (where clinically indicated) The patient will be given another appointment to return if they are accepted into the trial.

Treatment Intervention (Phase 2) Each patient will be randomly assigned (using random number allocation) to be filled with one of three filling materials; Glass Ionomer Cement (GIC), Resin Modified Glass Ionomer Cement (RMGIC) and BiodentineTM. Treatment groups will be randomized and adjusted for the covariates age, gender and caries experience. Once it has been determined which filling material is to be placed in each lesion the treatment intervention stage will proceed as follows;

  1. Scaling/prophylaxis to remove plaque and calculus
  2. Removal of carious tissue from Class V lesions with hand or rotary instruments and restoration of the resulting cavities with the randomly assigned filling material

They will then be given review appointments for 6 months, one year, 18 months and two years. They will be sent appointment cards with the date of the next appointment by post and a phone call to confirm it.

Review Appointment (Phase 3) At each review appointment the following data will be gathered;

  1. Survival and integrity of the restorations (according to USPHS Criteria)
  2. Wear rates of the restorations (by means of dental impressions and contact profilometry)

Blinding A suitably trained examiner will assess the survival and integrity of the restorations placed by the principal investigator to eliminate potential bias.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland, 0000
        • Cork University Dental School and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Calcium silicate cement
Biodentine
Device: Calcium silicate cement
Calcium silicate cement
Other Names:
  • Biodentine
ACTIVE_COMPARATOR: Glass Ionomer Cement
Fuji IX
Device: Glass Ionomer Cement
Glass Ionomer Cement
Other Names:
  • Fuji IX
ACTIVE_COMPARATOR: Resin Modified Glass Ionomer Cement
Fuji II LC
Device: Resin Modified Glass Ionomer Cement
Resin Modified Glass Ionomer Cement
Other Names:
  • Fuji II LC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (ESTIMATE)

May 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Root Caries Cork

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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