Clinical Trial on Periodontitis, Intrabony Periodontal Defect, Periodontal Regeneration - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, E1 1BB
    - Barts Health NHS Trust Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with pocket closure at worst site per mouth for intrabony defects Time Frame: Through study completion, an average of 2 years	Pocket closure is defined as PPD < and = 4 mm with no bleeding on probing (BoP)	Through study completion, an average of 2 years

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Barts & The London NHS Trust

Investigators

Principal Investigator: Nikolaos Gkranias, PhD, Centre for Oral Clinical Research, QMUL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

280800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Outcome Measure	Measure Description	Time Frame
% of patients with pocket closure at worst site per mouth for intrabony defects Time Frame: Measured at Timepoint 1 (from 6 months up to 1 year)	Secondary outcome	Measured at Timepoint 1 (from 6 months up to 1 year)
Changes in periodontal probing pocket (PPD) for intrabony defects at site and patient level. Time Frame: 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 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)
Changes in clinical attachment level (CAL) for intrabony defects at site and patient level. Time Frame: 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 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)
Changes in horizontal furcation involvement Time Frame: 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 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)
Changes in vertical CAL for furcation defects Time Frame: 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 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)
Change in diagnosis of periodontal disease Time Frame: 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 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)
Radiographic bone levels changes at site level Time Frame: 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 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)
Radiographic bone levels changes at tooth level Time Frame: 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 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)
Tooth loss Time Frame: 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 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)
Correlation of pocket closure to type of surgical approach used (minimally invasive approach, papilla preservation flaps, conventional flaps) Time Frame: 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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Correlation of pocket closure to biomaterials used Time Frame: 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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Correlation of pocket closure to diabetes status Time Frame: 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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Correlation of pocket closure to smoking history Time Frame: 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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Correlation of pocket closure to supportive periodontal therapy frequency Time Frame: 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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Correlation of pocket closure to level of clinician's experience Time Frame: 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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

Outcomes of Periodontal Regenerative Treatment

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