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PeriodontitisNCT04971174

Outcomes of Periodontal Regenerative Treatment

An observational study of Periodontitis and Intrabony Periodontal Defect, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
126 participants
Where
1 siteUnited Kingdom
Study dates
30 Sep 2022to 31 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.
  • Unable or unwilling to give consent
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Barts Health NHS Trust Dental Hospital

    London, E1 1BB

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Medical subject headings
Periodontitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % of patients with pocket closure at worst site per mouth for intrabony defects

    Pocket closure is defined as PPD < and = 4 mm with no bleeding on probing (BoP)

    Measured: Through study completion, an average of 2 years

Secondary outcomes (15)
  1. % of patients with pocket closure at worst site per mouth for intrabony defects

    Secondary outcome

    Measured: Measured at Timepoint 1 (from 6 months up to 1 year)

  2. Changes in periodontal probing pocket (PPD) for intrabony defects at site and patient level.

    Secondary outcome

    Measured: 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)

  3. Changes in clinical attachment level (CAL) for intrabony defects at site and patient level.

    Secondary outcome

    Measured: 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)

  4. Changes in horizontal furcation involvement

    Secondary outcome

    Measured: 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)

  5. Changes in vertical CAL for furcation defects

    Secondary outcome

    Measured: 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)

  6. Change in diagnosis of periodontal disease

    Secondary outcome

    Measured: 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)

  7. Radiographic bone levels changes at site level

    Secondary outcome

    Measured: 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)

  8. Radiographic bone levels changes at tooth level

    Secondary outcome

    Measured: 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)

  9. Tooth loss

    Secondary outcome

    Measured: 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)

  10. Correlation of pocket closure to type of surgical approach used (minimally invasive approach, papilla preservation flaps, conventional flaps)

    Secondary outcome- Measured as % of sites with pocket closure (PPD< and = 4mm with no BoP)

    Measured: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

  11. Correlation of pocket closure to biomaterials used

    Secondary outcome- Measured as % of sites with pocket closure (PPD< and = 4mm with no BoP)

    Measured: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

  12. Correlation of pocket closure to diabetes status

    Secondary outcome- Measured as % of sites with pocket closure (PPD< and = 4mm with no BoP)

    Measured: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

  13. Correlation of pocket closure to smoking history

    Secondary outcome- Measured as % of sites with pocket closure (PPD< and = 4mm with no BoP)

    Measured: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

  14. Correlation of pocket closure to supportive periodontal therapy frequency

    Secondary outcome- Measured as % of sites with pocket closure (PPD< and = 4mm with no BoP)

    Measured: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

  15. Correlation of pocket closure to level of clinician's experience

    Secondary outcome- Measured as % of sites with pocket closure (PPD< and = 4mm with no BoP)

    Measured: Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start30 Sep 2022
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04971174
Sponsor's protocol ID
280800
Status last verified
Feb 2026
First submitted
22 Jun 2021
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cortellini P, Buti J, Pini Prato G, Tonetti MS. Periodontal regeneration compared with access flap surgery in human intra-bony defects 20-year follow-up of a randomized clinical trial: tooth retention, periodontitis recurrence and costs. J Clin Periodontol. 2017 Jan;44(1):58-66. doi: 10.1111/jcpe.12638. Epub 2016 Nov 22.

    PubMed 27736011
  • Cortellini P, Tonetti MS. Long-term tooth survival following regenerative treatment of intrabony defects. J Periodontol. 2004 May;75(5):672-8. doi: 10.1902/jop.2004.75.5.672.

    PubMed 15212349
  • Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.

    PubMed 25867990
  • Guerrero A, Griffiths GS, Nibali L, Suvan J, Moles DR, Laurell L, Tonetti MS. Adjunctive benefits of systemic amoxicillin and metronidazole in non-surgical treatment of generalized aggressive periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2005 Oct;32(10):1096-107. doi: 10.1111/j.1600-051X.2005.00814.x.

    PubMed 16174275
  • Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.

    PubMed 1058213
  • Jepsen S, Topoll H, Rengers H, Heinz B, Teich M, Hoffmann T, Al-Machot E, Meyle J, Jervoe-Storm PM. Clinical outcomes after treatment of intra-bony defects with an EMD/synthetic bone graft or EMD alone: a multicentre randomized-controlled clinical trial. J Clin Periodontol. 2008 May;35(5):420-8. doi: 10.1111/j.1600-051X.2008.01217.x. Epub 2008 Mar 12.

    PubMed 18341601
  • Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.

    PubMed 25261053
  • Lang NP, Bartold PM. Periodontal health. J Clin Periodontol. 2018 Jun;45 Suppl 20:S9-S16. doi: 10.1111/jcpe.12936.

    PubMed 29926485
  • Linares A, Cortellini P, Lang NP, Suvan J, Tonetti MS; European Research Group on Periodontology (ErgoPerio). Guided tissue regeneration/deproteinized bovine bone mineral or papilla preservation flaps alone for treatment of intrabony defects. II: radiographic predictors and outcomes. J Clin Periodontol. 2006 May;33(5):351-8. doi: 10.1111/j.1600-051X.2006.00911.x.

    PubMed 16634957
  • Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Bragger U, Zwahlen M, Lang NP. Influence of residual pockets on progression of periodontitis and tooth loss: results after 11 years of maintenance. J Clin Periodontol. 2008 Aug;35(8):685-95. doi: 10.1111/j.1600-051X.2008.01245.x. Epub 2008 Jul 23.

    PubMed 18549447

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Intrabony Periodontal Defect, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of patients with pocket closure at worst site per mouth for intrabony defects (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971174, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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