NCT04971174已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
研究概览
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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))
研究者
研究点 (1)
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