Outcomes of Periodontal Regenerative Treatment
- Conditions
- PeriodontitisIntrabony Periodontal DefectPeriodontal Regeneration
- Registration Number
- NCT04971174
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
The aim of this recall study is to evaluate outcomes of surgical regenerative treatment of periodontal defects in a cohort of patient previously treated for gum disease at the Royal London Hospital as part of their periodontal care.
- Detailed Description
This study will be divided in two parts:
Part 1: a retrospective analysis of short-term outcomes of periodontal regenerative procedures undertaken at the Barts Royal London Dental Hospital (RLDH); Part 2: a single recall visit study in which patients identified through part 1 and willing to consent for the study will be reassessed for medium-term outcomes of the regenerative procedures previously undertaken.
For part 1 historic data will be collected from available dental records at RLDH and divided in:
* Timepoint 0: the latest available full mouth periodontal assessment before surgery and x-ray of site/s needing surgical intervention
* Timepoint 1: the latest available full mouth periodontal assessment after surgery and x-ray of same site/s at Timepoint 0
For part 2 data will be collected from patients identified through part 1 and willing to give consent for a single study recall visit:
•Timepoint 2: single study outcome recall visit (full mouth periodontal assessment and x-ray of same site/s at Timepoint 0).
Due to the nature of the study, the time elapsed between Timepoint 0 and Timepoint 2 can vary between 1 and 4 years.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
Inclusion criteria for part 1 of the study:
- Patient age 18 and older
- Patients that received periodontal regenerative surgical treatment at Barts RLDH from January 2017 to January 2019 with and without the use of any biomaterials, bone graft/substitute and membrane or combinations of those.
- Available full periodontal examination records after non surgical therapy to serve as a baseline for the study and not beyond 12 months before surgery
- Available radiographic examination of the tooth treated with surgical regenerative procedure at initial examination or after non surgical therapy to serve as a baseline for the study.
Additional inclusion criteria for part 2:
-Patient able and willing to give informed consent
Exclusion criteria for part 1:
- All the patients that do not match the inclusion criteria will be excluded from part 1.
- Patients that received regenerative surgical treatment for the management of gingival recession.
Exclusion criteria for part 2:
- Unable or unwilling to give consent
- Pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % of patients with pocket closure at worst site per mouth for intrabony defects Through study completion, an average of 2 years Pocket closure is defined as PPD \< and = 4 mm with no bleeding on probing (BoP)
- Secondary Outcome Measures
Name Time Method Changes in periodontal probing pocket (PPD) for intrabony defects at site and patient level. Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Changes in horizontal furcation involvement Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Changes in vertical CAL for furcation defects Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Change in diagnosis of periodontal disease Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Tooth loss Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Correlation of pocket closure to supportive periodontal therapy frequency Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome- Measured as % of sites with pocket closure (PPD\< and = 4mm with no BoP)
Correlation of pocket closure to level of clinician's experience Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome- Measured as % of sites with pocket closure (PPD\< and = 4mm with no BoP)
Radiographic bone levels changes at tooth level Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Correlation of pocket closure to type of surgical approach used (minimally invasive approach, papilla preservation flaps, conventional flaps) Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome- Measured as % of sites with pocket closure (PPD\< and = 4mm with no BoP)
Correlation of pocket closure to diabetes status Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome- Measured as % of sites with pocket closure (PPD\< and = 4mm with no BoP)
Correlation of pocket closure to smoking history Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome- Measured as % of sites with pocket closure (PPD\< and = 4mm with no BoP)
% of patients with pocket closure at worst site per mouth for intrabony defects Measured at Timepoint 1 (from 6 months up to 1 year) Secondary outcome
Radiographic bone levels changes at site level Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Changes in clinical attachment level (CAL) for intrabony defects at site and patient level. Changes measured from baseline (Timepoint 0) to Timepoint 1( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome
Correlation of pocket closure to biomaterials used Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years) Secondary outcome- Measured as % of sites with pocket closure (PPD\< and = 4mm with no BoP)
Trial Locations
- Locations (1)
Barts Health NHS Trust Dental Hospital
🇬🇧London, United Kingdom