The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Ridge Width Changes (RW)
研究概览
简要总结
The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period.
Central to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all?
To address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts.
Each participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.
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
The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (male or female) over 18 years of age.
- •Partially edentulous spaces.
- •No history of bone augmentation procedures in the implant site.
- •Good oral health, as measured by:
- •Calibrated gingival bleeding index (≤10%)
- •O'Leary plaque index (<10%)
排除标准
- •Bleeding disorders.
- •Compromised immune systems.
- •Excessive smoking or alcohol consumption.
- •Poor oral hygiene.
- •Diabetes.
- •Inability to attend follow-up visits.
研究组 & 干预措施
0 PRF
Each implant placed in this group did NOT have PRF membrane placed over the implant.
干预措施: Dental implant placement without PRF (Procedure)
1 PRF
Each implant placed in this group had ONE PRF membrane placed over the implant.
干预措施: Single-layer PRF membrane application (Biological)
3 PRF
Each implant placed in this group had THTEE STACKED PRF membranes placed over the implant.
干预措施: Triple-layer PRF membrane application (Biological)
结局指标
主要结局
Ridge Width Changes (RW)
时间窗: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Bone Width (BW)
时间窗: Baseline (preoperative), and 12 weeks postoperatively
Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
Change in width of keratinized tissue (KTW)
时间窗: Baseline (preoperative), 6 weeks, and 12 weeks
Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.
Keratinized Tissue Thickness (KTT)
时间窗: Baseline (preoperative), and 12 weeks postoperatively
Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.
Radiographic Mucosal Thickness (RT)
时间窗: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks
Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.
Crestal Bone Height (BH)
时间窗: Immediate postoperative, 6 weeks, and 12 weeks
Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.
次要结局
- Plaque Index (PI)(Baseline (preoperative), 6 weeks, and 12 weeks)
- Gingival Index (GI)(Baseline (preoperative), 6 weeks, and 12 weeks)
研究者
Ahmed Mahir Tawfeeq Karakchi
Principal Investigator
Al-Mustansiriyah University