Regenerative Treatment of Intrabony Defects With GTR and PRGF: A Randomised, Single-blind, Parallel-group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changed in Probing Pocket Depth (PPD)
研究概览
简要总结
The aim of this 12-month clinical study is to treat patients affected by gum disease (periodontitis) by a minor gum surgery that aims to reduce the depth of the gum pockets. In particular, the study will compare two types of gum surgery, one based on the use of a product derived from the patients' own blood (PRGF, platelet autologous concentrate), and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years. Both procedures aim to regenerate bone and gum tissue that is damaged by the disease. 74, ≥ 25-year-old, otherwise healthy, patients affected by gum disease will be recruited at the Barts and The London Dental Hospital. Participants will be randomly (by chance) assigned to receive one of the two treatments. Throughout the study, we will assess gum's health by taking some measurements around teeth and gums. In addition, we will use non-invasive technologies to assess changes in temperature, blood flow and face's swelling at different time-points. Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life. One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery, as per standard procedure.
详细描述
This is a randomized, single-blind, parallel-group controlled trial comparing the efficacy of GTR and PRGF ENDORET in the treatment of periodontal intrabony defects. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement.
No negative control (SPPF alone) has been considered for this project since several studies have demonstrated that guided tissue regeneration (GTR) associated or not with bone grafts results in better clinical outcomes than access flap alone in the treatment of periodontal intrabony defects.
The study consists of 9 visits over a minimum period of 13 months and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
Visit 1 - Baseline -
- Informed consent, medical/dental history and demographics
- Record concomitant medications and smoking history
- Height and weight measurement
- Standardised peri-apical x-ray in the area selected for the study
- Periodontal assessment by a blind and calibrated examiner, consisting of full mouth PPD, REC, BOP, mobility and furcation involvement will be recorded. PPD, REC, plaque and BOP will be recorded at 6 sites per tooth.
- Intra-oral 3D scan in the area selected for the study
- PROMs assessment (OIDP, and Global ratings of Periodontal Health and Quality of Life, EuroQoI-5D-5L)
- 3D extra-oral morphometric and Thermal scan
- Laser speckle contrast imaging, LSCI
- Pre-treatment hygiene phase, including supragingival scale and polish of all teeth and oral hygiene instructions
- Randomization to one of the two treatment groups by the study co-ordinator. The treatment allocation will be concealed in an opaque envelope. A treatment visit will be scheduled within the following 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, both participants and clinicians performing the surgical intervention will be unblinded. Conversely, outcome examiners will be blinded to treatment allocation.
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy males and females ≥25 years old
- •Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- •Clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm, with associated intrabony defect ≥3mm in any area of their mouth (excluding third molars and distal of second molars)
- •Full mouth bleeding and plaque scores (FMBS and FMPS) <25%recorded within the previous 6 weeks
- •Non-surgical treatment completed within 6 months prior to assessment for eligibility
排除标准
- •Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
- •Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam.
- •In chronic treatment (>2 weeks) with anticoagulants, corticosteroids or other medications that can severely impact on bone formation
- •History of alcohol or drug abuse.
- •Smoking ≥10 cigarettes a day
- •Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results).
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- •Periodontal surgery in the same area selected for the study within the past 12 months.
研究组 & 干预措施
Simplified Papilla Preservation Flap (SPPF) and PRGF
干预措施: Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16) (Procedure)
Simplified Papilla Preservation Flap (SPPF) and GTR
干预措施: Simplified Papilla Preservation Flap (SPPF) and GTR (Procedure)
结局指标
主要结局
Changed in Probing Pocket Depth (PPD)
时间窗: 12 months after treatment
Changes in PPD from baseline to 12 months after treatment
次要结局
- PROMs based on Global ratings of Periodontal Health and Quality of Life(At baseline, 4 weeks after surgery (visit 2), 3 months after surgery, 6 months after surgery, 12 months after surgery.)
- Post-operative swelling and oedema(At baseline, within 6 weeks from baseline (at visit 2 - surgical intervention), 2, 7 and 14 days after surgical intervention (visit 2))
- Radiographic bone changes(From baseline to 12 months post-surgery)
- PROMs based on the evaluation of global changes in quality of life(At baseline, 2 days after surgery (visit 2), 7 days after surgery, 14 days after surgery, 4 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery.)
- Changes in blood flow(At baseline and 2, 7 and 14 days after surgical intervention (visit 2))
- Patients' reported outcomes (PROMs) in Oral Impact on Daily Performances (OIDP) questionnaire (OIDP).(At baseline, 3 months after surgery (visits 2), 6 months after surgery, 12 months after surgery.)
- PROMs based on the evaluation of patient perception about therapy(At baseline, 2 days after surgery (visit 2), 7 days after surgery, 14 days after surgery, 4 weeks after surgery.)