Effect Of T-PRF Bandage on Pain and Epithelial Wound Healing at Palatal Donor Site: An Examiner-Masked, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The aim of this randomized controlled clinical trial is to assess the effect of Titanium prepared, platelet-rich fibrin (T-PRF) membranes on healing and re-epithelization of palatal wounds resulting from free gingival graft (FGG) harvesting.
研究概览
简要总结
Freegingival graft (FGG) is a successful treatment for deficiency of keratinizedsoft tissue surrounding teeth and implants. In the conventional FGG procedure,the keratinized gingiva consisting of epithelium and a thin layer of underlyingconnective tissue from the donor site is transferred to the recipient site. Itis suggested that 2 mm of keratinized tissue is adequate to maintain gingivaland peri-implanter health. The keratinized gingiva surrounding the teeth andimplants increases the resistance of the tissues to shrinkage and providesstability during prosthetic procedures. In cases where there is insufficient attachedgingiva/peri-implant keratinized mucosa, it is necessary to increase the amountof attached soft tissue by using mucogingival surgical methods such as FGGprocedures.7-11
Aplatelet-rich fibrin clot (PRF) is preferred for the stabilization andrevascularization of hard and soft tissue grafts due to their growth factorsand plays a decisive role in haemostasis with its coagulating factors. From themoment it is applied to the area, it turns into a kind of biological adhesiveshield that can consolidate the first set of platelets, thereby creating avascularized protective wall to decrease the risk of contamination bymicroorganisms. The acceleration of vascularization due to growth factors, absenceof toxic or allergic reactions due to autogenous graft, being economical andbiocompatible are some of the advantages of applying PRF to the donor site. Inrecent years, titanium-prepared PRF (T-PRF) which is based on the hypothesisthat titanium tubes may be more effective activating platelets than the glasstubes are used as an alternative for PRF. It has been stated that the contact ofPRF and the silica is inevitable due to the preparation in a glass tube whichmakes the affiliation weaker in conventional PRF. Besides, the activation ofplatelets with titanium compared with activation with silica particles mightprovide increased biocompatibility due to possible adverse effects of silicaparticles. Several studies revealed that T-PRF has a longer resorption timethan conventional PRF.12
Therefore,this study aimed to assess the healing effect of T-PRF clot membranes inpalatal wounds after FGG harvesting and to compare the postsurgical painexperience and complications with a conventional procedure where a gelatinesponge was placed in the palatal wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Age more than 18 years.
- •Without systemic diseases, No medical contraindications for periodontal surgery, and Adequate level of plaque control (plaque index < 15%).
排除标准
- •Systemically compromised patients e.g.-uncontrolled diabetes Patients who are on medications that could interfere with wound healing.
- •Patients having to use removable partial denture for the upper arch.
- •Pregnant and lactating females.
- •Evidence of Malocclusion, or Crowding or any other local factors complicating the overall prognosis of the area.
结局指标
主要结局
The aim of this randomized controlled clinical trial is to assess the effect of Titanium prepared, platelet-rich fibrin (T-PRF) membranes on healing and re-epithelization of palatal wounds resulting from free gingival graft (FGG) harvesting.
时间窗: Baseline,2 Months
次要结局
- To assess the level of wound healing and epithelization by the use of TPRF on FGG extracted site during wound healing post-surgery in the test group.(To assess the level of wound healing and epithelization on the FGG extracted site during wound healing post-surgery in the control group.)
