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
Verified date | December 2023 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barts Health NHS Trust Dental Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | Barts & The London NHS Trust |
United Kingdom,
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
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) |
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