Clinical trial NCT04971174: Outcomes of Periodontal Regenerative Treatment
Official title: Short & Medium Term Outcomes of Periodontal Regenerative Procedures. A Two-part Study With a) Analysis of Periodontal Records of a Cohort of Periodontitis Patients and b) a Single Visit Recall and Comprehensive Periodontal Re-evaluation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Periodontitis
Intrabony Periodontal Defect
Periodontal Regeneration
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
First posted: 2021-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of patients that underwent surgical periodontal regenerative treatment at RLDH between January 2017 and January 2019 will be the study population for part 1 of the study.

For the part 2 of the study these patients will be contacted and asked to participate in the recall study. The patients willing to participate into the single recall visit outcome study will form the study population for part 2.

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: % of patients with pocket closure at worst site per mouth for intrabony defects
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: % of patients with pocket closure at worst site per mouth for intrabony defects
timeFrame: Measured at Timepoint 1 (from 6 months up to 1 year)
measure: Changes in periodontal probing pocket (PPD) for intrabony defects at site and patient level.
timeFrame: 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)
measure: Changes in clinical attachment level (CAL) for intrabony defects at site and patient level.
timeFrame: 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)
measure: Changes in horizontal furcation involvement
timeFrame: 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)
measure: Changes in vertical CAL for furcation defects
timeFrame: 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)
measure: Change in diagnosis of periodontal disease
timeFrame: 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)
measure: Radiographic bone levels changes at site level
timeFrame: 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)
measure: Radiographic bone levels changes at tooth level
timeFrame: 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)
measure: Tooth loss
timeFrame: 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)
measure: Correlation of pocket closure to type of surgical approach used (minimally invasive approach, papilla preservation flaps, conventional flaps)
timeFrame: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
measure: Correlation of pocket closure to biomaterials used
timeFrame: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
measure: Correlation of pocket closure to diabetes status
timeFrame: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
measure: Correlation of pocket closure to smoking history
timeFrame: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
measure: Correlation of pocket closure to supportive periodontal therapy frequency
timeFrame: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
measure: Correlation of pocket closure to level of clinician's experience
timeFrame: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust Dental Hospital
Study officials:
affiliation: Centre for Oral Clinical Research, QMUL
name: Nikolaos Gkranias, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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