Autologous Platelet Concentrate (APC) in Intrabony Defects

Summary

Participation Requirements

Description

This is a randomized, single-blind, parallel-group controlled trial comparing the efficacy of GTR and PRGF ENDORET in the treatment of periodontal intrabony defects. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement. No negative control (...

This is a randomized, single-blind, parallel-group controlled trial comparing the efficacy of GTR and PRGF ENDORET in the treatment of periodontal intrabony defects. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement. No negative control (SPPF alone) has been considered for this project since several studies have demonstrated that guided tissue regeneration (GTR) associated or not with bone grafts results in better clinical outcomes than access flap alone in the treatment of periodontal intrabony defects. The study consists of 9 visits over a minimum period of 13 months and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London. Visit 1 - Baseline - Informed consent, medical/dental history and demographics Record concomitant medications and smoking history Height and weight measurement Standardised peri-apical x-ray in the area selected for the study Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth. Intra-oral 3D scan in the area selected for the study PROMs assessment (OIDP, and Global ratings of Periodontal Health and Quality of Life, EuroQoI-5D-5L) 3D extra-oral morphometric and Thermal scan Laser speckle contrast imaging, LSCI Pre-treatment hygiene phase, including supragingival scale and polish of all teeth and oral hygiene instructions Randomization to one of the two treatment groups by the study co-ordinator. The treatment allocation will be concealed in an opaque envelope. A treatment visit will be scheduled within the following 6 weeks. Visit 2 - Surgical intervention - (within 6 weeks from Visit 1) Query to update medical/dental history and record adverse events and/or concomitant medications Recording of the number of defect walls Study treatment according to randomization (PRGF ENDORET or GTR) Intra-oral 3D scan in the area selected for the study (scan taken immediately after surgery) Record of surgery time Post-surgical instructions 3D extra-oral morphometric and thermal scan (scan taken immediately after surgery) Visit 3 - 2 days follow-up - (2 days ±1 days from Visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Visual assessment of gingival healing and recording of early healing index (EHI) Laser speckle contrast imaging, LSCI Intra-oral 3D scan in the area selected for the study 3D extra-oral morphometric and Thermal scan PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy) Visit 4 - Suture removal - (7 days +3 days from visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Visual assessment of gingival healing and recording of early healing index (EHI) Laser speckle contrast imaging, LSCI Intra-oral 3D scan in the area selected for the study 3D extra-oral morphometric and Thermal scan Suture removal Supra-gingival polishing and reinforcement of oral hygiene instructions PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy) Visit 5 - 2 weeks follow up visit- (14 days ±3 days from visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Visual assessment of gingival healing and recording of early healing index (EHI) Laser speckle contrast imaging, LSCI Intra-oral 3D scan in the area selected for the study 3D extra-oral morphometric and thermal scan Supra-gingival polishing and reinforcement of oral hygiene instructions PROMs assessment (Evaluation of global changes in quality of life and evaluation of patient perception about therapy) Visit 6 - 4 weeks follow up visit- (28 days ±3 days from visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Visual assessment of gingival healing Intra-oral 3D scan in the area selected for the study 3D extra-oral morphometric and Thermal scan Supra-gingival polishing and reinforcement of oral hygiene instructions PROMs assessment (Global ratings of Periodontal Health and Quality of Life, Evaluation of global changes in quality of life, and Eevaluation of patient perception about therapy and EuroQoI-5D-5L) Visit 7 - 3 months follow up visit- (3 months ±7 days from visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Recording of PPD, REC, BOP, PI and mobility on the tooth involved in the surgical intervention and 2 adjacent teeth by a blind and calibrated examiner PROMs assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L) Supra-gingival polishing and reinforcement of oral hygiene instructions Visit 8 - 6 months follow up visit- (6 months ±7 days from visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Recording of PPD, REC, BOP, PI and mobility on the tooth involved in the surgical intervention and 2 adjacent teeth by a blind and calibrated examiner Supra-gingival polishing and reinforcement of oral hygiene instructions PROMsS assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L) Visit 9 - 12 months follow up visit- (12 months ±7 days from visit 2) Query to update medical/dental history and record adverse events and/or concomitant medications Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth. PROMS assessment (OIDP, Global ratings of Periodontal Health and Quality of Life, and eEvaluation of global changes in quality of life and EuroQoI-5D-5L) Supra-gingival polishing and reinforcement of oral hygiene instructions Standardised peri-apical x-ray in the area selected for the study Study randomisation and treatment allocation Following completion of the preparation treatment all individuals enrolled into the study will be randomly assigned to one of the treatment groups. Simplified Papilla Preservation Flap (SPPF) and guided tissue regeneration (GTR) with a porcine collagen membrane and a deproteinized bovine bone substitute. Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET. A balanced random permuted block approach (4-unit block size) will be used to prepare the randomisation tables. Minimisation will be carried out to facilitate balancing of smokers in each group. Allocation to treatment will take place via the study coordinator (or one of their delegate). Treatment allocation details will be concealed in an opaque envelope at the study site. At the time of enrollment, each participant will be sequentially issued a subject ID. The subject ID consists of two initials and a number. The ID number will consist of three digits and will be assigned in ascending numerical order beginning with 001.

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