Outcomes of Periodontal Regenerative Treatment

NCT04971174 | Completed

• 1 other identifier: 280800
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect; Periodontitis; Periodontal Regeneration

Outcome Measures

Primary Outcomes (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)

  Through study completion, an average of 2 years

Secondary Outcomes (15)

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

  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.

  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.

  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

  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

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Patient able and willing to give informed consent

You may not qualify if:

• Patients that received regenerative surgical treatment for the management of gingival recession.
• Unable or unwilling to give consent
• Pregnant women

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator

Study Sites (1)

Barts Health NHS Trust Dental Hospital

London, E1 1BB, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 27736011 BACKGROUND

• 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.

  PMID: 15212349 BACKGROUND

• 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.

  PMID: 25867990 BACKGROUND

• 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.

  PMID: 16174275 BACKGROUND

• 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.

  PMID: 1058213 BACKGROUND

• 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.

  PMID: 18341601 BACKGROUND

• 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.

  PMID: 25261053 BACKGROUND

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

  PMID: 29926485 BACKGROUND

• 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.

  PMID: 16634957 BACKGROUND

• 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.

  PMID: 18549447 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nikolaos Gkranias, PhD

  Centre for Oral Clinical Research, QMUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 21, 2021
• Study Start: September 30, 2022
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)