Imaging analysis following periodontal surgery
Research type
Research Study
Full title
The use of non-invasive thermal and geometrical surface imaging on postoperative healing patterns following routine surgical procedures used for the treatment of periodontal disease: a single centre, randomised, single blind, parallel group clinical trial.
IRAS ID
218861
Contact name
Nikos Donos
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is a randomised, single blind, parallel group clinical trial assessing the use of a 3D&2D surface camera imaging technology, applied extra and intra orally to evaluate postoperative healing patterns following 2 routine surgical procedures used for the treatment of periodontal (gum) disease. The secondary aim of the trial is to correlate this to patient reported outcome measures (PROMs) and clinical parameters and relate these to the 2D and 3D imaging outcomes. The 2 surgical approaches to be compared are the Simplified Papilla Preservation Flap (conservative surgery aiming at preserving the tissues between teeth) and the conventional Resective Periodontal Flap with Osseous Recontouring (involves resection of soft and hard tissues).
Periodontal surgical procedures have an effect on patients as they involve postoperative complications and are costly. There is a limited body of research evaluating the complications of these 2 surgical approaches. Utilising a 3D&2D image analysis is an inexpensive, non-invasive and fast way to provide a visual comparison of the post operative process in these 2 surgical techniques and correlate this to PROMs.
There will be 58 subjects presenting with evidence of periodontal disease requiring a surgical intervention. They will be recruited and treated in the NHS site; Bart's and The London Dental hospital; and have their 2D&3D oral imaging taken at QMUL's Institute of Dentistry oral imaging facility. The study will last for 22 months and the patients will undergo a baseline and pre treatment oral hygiene visits for clinical measurements, oral hygiene instruction and teeth cleaning. The patients will then be randomised to the surgical procedures and reviewed at 1,3,7,14,30&90 days post operatively during which they will have the 2D&3D imaging and PROMS questionnaire. The sutures (stitches) will be removed at day 7 and a final periodontal examination with oral hygiene instruction will be carried out on day 90.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
17/LO/1428
Date of REC Opinion
1 Nov 2017
REC opinion
Further Information Favourable Opinion