Platelet Rich Fibrin and Autologous Fibrin Glue for Treating Periodontal Recession Defects: a Comparative Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Evaluate the level of root coverage using PRF plus AFG with a coronally advanced flap or PRF only with a CAF compared to subepithelial connective tissue graft with a CAF for Class 1 and 2 gingival recession defects.
研究概览
简要总结
Platelet-rich fibrin (PRF) and Autologous Fibrin Glue (AFG) are fibrin preparation derived from human blood samples and are used in regenerative dentistry.
Aim: The aim of this study is to evaluate the level of root coverage using PRF (+) AFG with a coronally advanced flap (CAF) or PRF only with a CAF compared to a sub-epithelial connective tissue graft (CTG) with a CAF for treating Class 1 and 2 gingival recession defects. Additionally, to evaluate the level of keratinized tissue tissue thickness and width using PRF (+) AFG with a CAF or PRF only with a CAF compared to CTG with CAF for Class 1 and 2 gingival recession defects.
Method: 48 patients with recession defects will be randomly divided into three different treatment groups. Treatment Group A (n=16) will consist of patients treated with PRF (+) AFG with a CAF, Group B (n=16) will consist of patients treated with PRF only with a CAF and Group C (n=16) will consits of patients treated with CTG with CAF as a control. Clinical measurements will be assessed at baseline and at 1 month and 6 months after the surgery. The clinical measurements that will be recorded, include probing depth, clinical attachment level, and gingval recession parameters. The gingival recession parameters include recession width, depth and thickness.
详细描述
Specific aim 1: Evaluate the level of root coverage using Platelet Rich Fibrin (PRF) plus Autologous Fibrin Glue (AFG) with a coronally advanced flap (CAF) or PRF only with a CAF compared to subepithelial connective tissue graft (CTG) with a CAF for Class 1 and 2 gingival recession defects.
Specific aim 2: Evaluate the level of keratinized tissue thickness and width using PRF plus AFG with a CAF, PRF only with a CAF or a SCTG with CAF for Class 1 and 2 gingival recession defects.
Research design and methods:
Subjects and treating clinician will not be aware of the treatment arm until immediately before the surgery. Each treatment arm will use the same surgical protocol for treating gingival recession and will differ by the material used to cover the tooth root. Intervention A will use PRF with the addition of AFG. Intervention B will use PRF. The control arm will use CTG.
Methods: A total of 48 patients with recession defects will be randomly assigned to three different treatment groups. Treatment group A (n=16) will consist of patients treated with PRF plus AFG with a CAF, Group B (n=16) will consist of patients treated with PRF with a CAF and Group C (n=16) will consist of patients treated with CTG with a CAF. Group C will be the control group. Clinical measurements, including recession defect length and gingival width and thickness, will be evaluated at baseline, one month and six months after treatment. For standardization, measurements will be taken using pre- fabricated stents with an endo file stopper. A visual analogue scale will be used to compare post-operative pain between the two procedures.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 years or over
- •Miller's Class 1 and Class 2 recession
- •Localized gingival recession of 1-6mm present on 1 or 2 continuous single rooted teeth. Gingival recession is measured from the cemental-enamel junction (CEJ; a stable anatomical landmark on every tooth) to the gingival margin.
排除标准
- •Current tobacco use (greater than 1 cigarette/week) or history of quitting < 5 years previously (self reported)
- •Poor oral hygiene (plaque index of 2 or greater) or active periodontal disease (diagnosis of moderate chronic periodontal disease or greater)
- •Currently taking aspirin, prescription blood thinners
- •Type II diabetes with HbA1c greater than 7
- •Immunosuppressed or any other systemic condition that would disqualify subject as an acceptable surgical candidate
研究组 & 干预措施
Group A - PRF plus AFG with a CAF
Group A - PRF plus AFG with a CAF: The PRF will be prepared according to the protocol outlined by Choukroun 1. Prior to the surgical procedure, venous blood will be collected via venipuncture from the antecubital vein using one 10 ml sterile glass tube and one 10ml sterile plastic tube. The tubes will be immediately centrifuged at 1300 rpm for 8 minutes to obtain PRF. The fibrin clot formed in the middle part of the tube will be collected. The clot will be transferred to the PRF box and compressed to form a membrane. For the AFG, the liquid will be separated from the red blood cells from the plastic tube using a sterile syringe.
干预措施: Group A - PRF plus AFG with a CAF (Other)
Group B - PRF only with a CAF
Group B - PRF only with a CAF: The PRF will be prepared according to the protocol outlined by Choukroun1. Prior to the surgical procedure, venous blood will be collected via venipuncture from the antecubital vein using one 10 ml sterile glass tube. The tubes will be immediately centrifuged at 1300 rpm for 8 minutes to obtain PRF. The fibrin clot formed in the middle part of the tube will be collected. The clot will be transferred to the PRF box and compressed to form a membrane.
干预措施: Group B - PRF only with a CAF (Other)
Group C - CTG with a CAF
Group C - CTG with a CAF: Sup-epithelial connective tissue harvest: The palatal donor site should be at least 3mm in thickness. A horizontal incision will be made on the palate 3mm from the maxillary canine to the first molar using a 15 blade. A sub-epithelial connective tissue graft will be harvested with adequate dimensions based on the recipient site. The graft will be sutured over the recipient site with 5-0 chromic gut sutures using a continuous mattress suturing technique.
干预措施: Group C - CTG with a CAF (Other)
结局指标
主要结局
Evaluate the level of root coverage using PRF plus AFG with a coronally advanced flap or PRF only with a CAF compared to subepithelial connective tissue graft with a CAF for Class 1 and 2 gingival recession defects.
时间窗: Baseline to 6 months
To evaluate the level of root coverage using PRF plus AFG compared to CTG or PRF only compared to CTG
次要结局
- Evaluate the level of keratinized tissue thickness and width using PRF plus AFG with a CAF, PRF only with a CAF or a SCTG with CAF for Class 1 and 2 gingival recession defects.(Baseline to 6 months)