Assessment of a new protocol for indirect pulp capping procedures
Research type
Research Study
Full title
Assessment of a new protocol for indirect pulp capping procedures
IRAS ID
156456
Contact name
Francesco Mannocci
Contact email
Sponsor organisation
King's College London Dental Institute
Research summary
Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. One group of patients will be treated with a standard clinical procedure, the other group will be treated with a more conservative clinical procedure with the aid of an operating microscope. The study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. An assessment of the overlying restoration will be made after 18 months. The study will also compare the sensitivity of 3D cone beam computed tomography (CBCT) scans with that of normal Xrays in detecting the presence of early bone changes around the roots of such teeth.
The study will be carried out at KCL Dental Institute at Guy's Hospital and will form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans. Potential volunteers will be given written information about the process (see attached information sheet) and be given time to consider participation. Once any questions have been answered, fully informed written consent will be obtained if they are interested in taking part. One deep cavity causing toothache requiring indirect pulp capping will be detected and diagnosed through conventional clinical and X-ray dental assessment.
The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will be at 6, 12 and 18 months. Radiographic assessment including cone beam computed tomography (CBCT) will be done at baseline and 12 months. It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.REC name
London - South East Research Ethics Committee
REC reference
14/LO/0880
Date of REC Opinion
9 Jul 2014
REC opinion
Further Information Favourable Opinion