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Completed

NCT Number: NCT04971174

Outcomes of Periodontal Regenerative Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barts Health NHS Trust Dental Hospital

London, E1 1BB, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. % 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)

Secondary outcomes

  1. % 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Barts & The London NHS Trust

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2021
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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