Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04254861
Status:
RECRUITING
Last Update Posted:
2023-05-30
First Post:
2020-01-27
Brief Title:
Autologous Platelet Concentrate APC in Intrabony Defects
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Regenerative Treatment of Intrabony Defects With GTR and PRGF A Randomised Single-blind Parallel-group Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this 12-month clinical study is to treat patients affected by gum disease periodontitis by a minor gum surgery that aims to reduce the depth of the gum pockets In particular the study will compare two types of gum surgery one based on the use of a product derived from the patients own blood PRGF platelet autologous concentrate and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years Both procedures aim to regenerate bone and gum tissue that is damaged by the disease 74 25-year-old otherwise healthy patients affected by gum disease will be recruited at the Barts and The London Dental Hospital Participants will be randomly by chance assigned to receive one of the two treatments Throughout the study we will assess gums health by taking some measurements around teeth and gums In addition we will use non-invasive technologies to assess changes in temperature blood flow and faces swelling at different time-points Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery as per standard procedure
Detailed 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 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 medicaldental 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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
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 medicaldental 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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 medicaldental history and record adverse events andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COCR0021 | OTHER | CORC | None |