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临床试验/NCT03023995
NCT03023995已完成3 期

Coronally Advanced Flap With Connective Tissue Graft and PRF for Recession Coverage

Dr. D. Y. Patil Dental College & Hospital0 个研究点目标入组 10 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
10
主要终点
Reduction in recession depth

研究概览

简要总结

Over the years, numerous surgical techniques such as free autografts and pedicle grafts have been introduced to correct gingival recession defects. Combination grafts with either autografts or allografts, and newer concepts of guided tissue regeneration (GTR), platelet concentrates, etc., were developed more recently to correct mucogingival defects. The use of PRF in various surgical procedures such as degree II furcations, intrabony defects, sinus floor segmentation during implant placement and on facial plastic surgeries have shown promising results. However to our knowledge, till this study was completed, no studies have been reported with the clinical outcomes of autologous platelet rich fibrin membrane for the treatment of localized gingival recession defects.

Hence, this study was designed to compare coronally advanced flap with platelet rich fibrin membrane versus subepithelial connective tissue graft in treatment of Miller's Class I and Class II gingival recession defects.

详细描述

The study design consist of twenty sites from ten patients were randomly selected by tossing the coin for the study, which are divided into test group( Root coverage was performed by coronally advanced flap with platelet rich fibrin membrane) and Control group (Root coverage was performed with coronal advanced flap with subepithelial connective tissue graft.)

The Surgical Procedure consist of i) Preparation of the recipient bed: After adequate anesthesia, trapezoidal flap was designed using three incisions which is followed by reflection of partial thickness flap was raised apical to the crest of the osseous dehiscence. A periosteal releasing incision was given to enable the coronal advancement of the flap. Following this, root planing was done and the mesial and distal interdental papillae were deepithelialized.

The exposed root surface was conditioned with tetracycline hydrochloride for four mins. (The tetracycline hydrochloride powder was mixed with saline in dappen dish and then applied on the root surface).

In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with non resorbable sutures. The surgical area was covered with a non - eugenol periodontal dressing with post-operative antibiotics and analgesics and post-operative instructions that were given to all the patients.

In control group, connective tissue graft harvesting was carried out which was followed by placement of connective tissue graft on the recipient site. The connective tissue graft was placed on the recipient site and secured in position with vicryl sutures. The flap was coronally positioned over the connective tissue graft and secured with non resorbable sutures. The recipient bed was covered with a non-eugenol periodontal dressing with post-operative antibiotics and analgesics and post- operative instructions that were given to all the patients.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients with age group between 20 to 55 years,
  • Presence of bilateral Millers Class I or II gingival recession defects,
  • Periodontally healthy patients,
  • Patient who demonstrate acceptable oral hygiene status prior to surgical procedure,
  • Patient with a medium to deep palatal vault (for Control Group only),
  • Patients agreed to give informed consent

排除标准

  • History of prolonged use of antibiotics / steroids /immunosuppressive agents/aspirin/anticoagulants/other medications,
  • Pregnant women,
  • History of systemic diseases like hypertension, diabetes, HIV, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer, etc.
  • Patients with unacceptable oral hygiene,
  • Faulty tooth brushing technique,
  • Mal-aligned tooth,
  • Cervical abrasion,
  • Teeth with prominent roots.

结局指标

主要结局

Reduction in recession depth

时间窗: Baseline to 6 months

Recession depth reduction from baseline to 6 months

次要结局

  • Reduction in Mean plaque scores(baseline to 6 months)
  • Change Relative attachment level(baseline to 6 months)
  • Reduction in mean gingival scores(Baseline to 6 months)
  • Width of keratinised tissue(baseline to 6 months)

研究者

发起方
Dr. D. Y. Patil Dental College & Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santosh Martande

Lecturer

Dr. D. Y. Patil Dental College & Hospital

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