Outcomes of Periodontal Regenerative Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Timepoint 0: the latest available full mouth periodontal assessment before surgery and x-ray of site/s needing surgical intervention
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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 Design
Outcome Measures
Primary Outcome Measures
- % of patients with pocket closure at worst site per mouth for intrabony defects [Through study completion, an average of 2 years]
Pocket closure is defined as PPD < and = 4 mm with no bleeding on probing (BoP)
Secondary Outcome Measures
- % of patients with pocket closure at worst site per mouth for intrabony defects [Measured at Timepoint 1 (from 6 months up to 1 year)]
Secondary outcome
- 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)]
Secondary outcome
- 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)]
Secondary outcome
- 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)]
Secondary outcome
- 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)]
Secondary outcome
- Change in diagnosis of periodontal disease [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
- Radiographic bone levels changes at site 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)]
Secondary outcome
- Radiographic bone levels changes at tooth 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)]
Secondary outcome
- Tooth loss [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
- Correlation of pocket closure to type of surgical approach used (minimally invasive approach, papilla preservation flaps, conventional flaps) [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)
- Correlation of pocket closure to biomaterials used [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)
- Correlation of pocket closure to diabetes status [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)
- Correlation of pocket closure to smoking history [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)
- Correlation of pocket closure to supportive periodontal therapy frequency [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)
- Correlation of pocket closure to level of clinician's experience [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion criteria for part 1 of the study:
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Patient age 18 and older
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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.
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Available full periodontal examination records after non surgical therapy to serve as a baseline for the study and not beyond 12 months before surgery
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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
- Patients that received regenerative surgical treatment for the management of gingival recession.
Exclusion criteria for part 2:
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Unable or unwilling to give consent
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barts Health NHS Trust Dental Hospital | London | United Kingdom | E1 1BB |
Sponsors and Collaborators
- Queen Mary University of London
- Barts & The London NHS Trust
Investigators
- Principal Investigator: Nikolaos Gkranias, PhD, Centre for Oral Clinical Research, QMUL
Study Documents (Full-Text)
None provided.More Information
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.
- 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. Review.
- Cortellini P, Tonetti MS. Long-term tooth survival following regenerative treatment of intrabony defects. J Periodontol. 2004 May;75(5):672-8.
- 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.
- Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35.
- Jepsen S, Topoll H, Rengers H, Heinz B, Teich M, Hoffmann T, Al-Machot E, Meyle J, Jervøe-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.
- Kassebaum NJ, Bernabé 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. Review.
- Lang NP, Bartold PM. Periodontal health. J Clin Periodontol. 2018 Jun;45 Suppl 20:S9-S16. doi: 10.1111/jcpe.12936. Review.
- Liñares 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.
- Matuliene G, Pjetursson BE, Salvi GE, Schmidlin K, Brägger 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.
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