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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Periodontitis
- 发起方
- Queen Mary University of London
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- % of patients with pocket closure at worst site per mouth for intrabony defects
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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:
- •Unable or unwilling to give consent
- •Pregnant women
结局指标
主要结局
% of patients with pocket closure at worst site per mouth for intrabony defects
时间窗: Through study completion, an average of 2 years
Pocket closure is defined as PPD \< and = 4 mm with no bleeding on probing (BoP)
次要结局
- 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 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- % of patients with pocket closure at worst site per mouth for intrabony defects(Measured at Timepoint 1 (from 6 months up to 1 year))
- 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))
- 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))
- 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))