Treatment of advanced grade III periodontal furcation lesions
Research type
Research Study
Full title
Clinical and patient reported outcomes following treatment of grade III furcation involved molars. A single-centre single-masked randomised controlled feasibility trial with a Sequential, Multiple Assignment Randomised Trial (SMART) design.
IRAS ID
277601
Contact name
Luigi Nibali
Contact email
Sponsor organisation
Vice President & Vice Principal (Research). King's College London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Gum disease (periodontitis) can result in the loss of the supporting bone around teeth. Periodontitis around back teeth (molars) can be challenging to treat as they have more than one root (multirooted) and bone loss can occur in the space between the roots (furcation), creating a furcation involvement (FI). The degree of FI is graded in terms of horizontal (I to III) and vertical (A-C) bone loss from the least to most severe.
Despite molar teeth being so important in mastication and the overall function of the dentition, there are currently no published guidelines for the most appropriate treatment for grade III FI molar teeth. The main aim of this study is to assess the feasibility of carrying out a large randomised controlled trial with SMART design and to assess the response of degree III furcation-involved molars to periodontal treatment (using a ‘combined outcome’ incorporating patient-reported outcomes (PROMS) and clinical and inflammatory parameters).
Patients aged 18-70 presenting to the Periodontology department at Guy’s Hospital with >1 grade III C molars will be offered to participate in this 12-month study. Each participant will undergo two treatments, 6 months apart. For treatment I, participants will be randomised to either non-surgical periodontal treatment (NSPT) or open flap debridement (OFD). Following a reassessment, treatment II will be a sequential follow-on. Participants will again be randomised. The consequent treatment received by a 'non-responder' will be a treatment which is ‘continued’, ‘stepped-up,’ or ‘augmented’ as per the principles of a SMART RCT.
Microbiological plaque bacteria and samples of saliva and gingival crevicular fluid from test and control sites will be collected. Self-reported questionnaires will be completed to provide information on participants' attitudes to their teeth and treatment. Data will be analysed and a report will be submitted 12 months after last patient last visit.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0256
Date of REC Opinion
7 Jan 2022
REC opinion
Further Information Favourable Opinion