Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01866059 |
| Other study ID # |
Root Caries Cork |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
May 28, 2013 |
| Last updated |
May 10, 2016 |
| Start date |
July 2012 |
| Est. completion date |
December 2018 |
Study information
| Verified date |
May 2016 |
| Source |
University College Cork |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Ireland: Research Ethics Committee |
| Study type |
Interventional
|
Clinical Trial 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.
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.
