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| Name | Class |
|---|---|
| Barts & The London NHS Trust | OTHER |
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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.
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| % 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 |
| Measure | Description | Time Frame |
|---|---|---|
| % 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) |
| Changes in periodontal probing pocket (PPD) for intrabony defects at site and patient level. |
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Inclusion Criteria:
Inclusion criteria for part 1 of the study:
Additional inclusion criteria for part 2:
-Patient able and willing to give informed consent
Exclusion Criteria:
Exclusion criteria for part 1:
Exclusion criteria for part 2:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Gkranias, PhD | Centre for Oral Clinical Research, QMUL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust Dental Hospital | London | E1 1BB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27736011 | Background | 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. | |
| 15212349 |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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. |
| 25867990 | 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. |
| 16174275 | 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. |
| 1058213 | 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. |
| 18341601 | 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. |
| 25261053 | 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. |
| 29926485 | Background | Lang NP, Bartold PM. Periodontal health. J Clin Periodontol. 2018 Jun;45 Suppl 20:S9-S16. doi: 10.1111/jcpe.12936. |
| 16634957 | 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. |
| 18549447 | 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. |