Outcomes of Periodontal Regenerative Treatment

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04971174
• Other study ID #: 280800
• Status: Enrolling by invitation
• Start date: September 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontal Regeneration
• Periodontitis

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust Dental Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	% of patients with pocket closure at worst site per mouth for intrabony defects	Secondary outcome	Measured at Timepoint 1 (from 6 months up to 1 year)
Secondary	Changes in periodontal probing pocket (PPD) for intrabony defects at site and patient level.	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)
Secondary	Changes in clinical attachment level (CAL) for intrabony defects at site and patient level.	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)
Secondary	Changes in horizontal furcation involvement	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)
Secondary	Changes in vertical CAL for furcation defects	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)
Secondary	Change in diagnosis of periodontal disease	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)
Secondary	Radiographic bone levels changes at site level	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)
Secondary	Radiographic bone levels changes at tooth level	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)
Secondary	Tooth loss	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)
Secondary	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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)
Secondary	Correlation of pocket closure to biomaterials used	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)
Secondary	Correlation of pocket closure to diabetes status	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)
Secondary	Correlation of pocket closure to smoking history	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)
Secondary	Correlation of pocket closure to supportive periodontal therapy frequency	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)
Secondary	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)	Assessed at Timepoint 1 ( from 6 months up to 1 year) and Timepoint 2 (through study completion, an average of 2 years)