Intrabony Periodontal Defect, Periodontal Regeneration, Periodontitis
Conditions
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.
Interventions
None listed
Sponsors
Queen Mary University of London
Barts & The London NHS Trust
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % 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
| Measure | Time frame | Description |
|---|---|---|
| % 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 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 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) |
| 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) |
| 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) |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORNikolaos Gkranias, PhD
Centre for Oral Clinical Research, QMUL
Outcome results
None listed