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临床试验/CTRI/2024/02/062289
CTRI/2024/02/062289尚未招募4 期

A Comparative evaluation of Platelet Rich Fibrin Matrix (PRFM) AND Coronally Advanced Flap(CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCs) in the surgical management of Gingival Recession Type 1 – A Split-mouth Randomised Controlled Trial.

DR JEEVIKA A DAS1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
9. Gingival Thickness (GT)

研究概览

简要总结

This is a split-mouth, double-blind, randomised controlled clinical trial for comparing the Platelet-Rich Fibrin Matrix (PRFM) and Coronally Advanced Flap (CAF) with and without Peripheral Blood Mesenchymal Stem Cells (PBMSCS) in the surgical management of gingival recession type – 1 for the evaluation of the root coverage potential, regenerative effects, and the impact on gingival thickness.. The sites will be randomly assigned by computer-generated tabulation method into: 1. Test group: treated with CAF and PBMSCS + PRFM (SUPERCELL). 2. Control group: treated with CAF and PRFM alone. The period of study will be divided into a screening phase, a pre-treatment phase, a treatment phase, and a post-treatment phase. The subjects will be recruited after meeting the inclusion and exclusion criteria and obtaining the informed consent during the screening phase. In pre-treatment phase all patients will initially receive phase i therapy consisting of scaling, root planing, and oral hygiene instructions. Clinical parameters like Plaque Index (Pi):  Silness And Loe, Gingival Index (Gi): Loe And Silness, Vertical Component Of The Gingival Recession, Horizontal Component Of The Gingival Recession, Probing Pocket Depth, Clinical Attachment Level, Width Of Attached Gingiva, Width Of Keratinized Gingiva, Gingival Thickness And Root Coverage Esthetic Score will be recorded at baseline, 3 months, 6 months, 1 year and 2 years. The treatment phase will involve withdrawal of blood for the procurement of PRFM and PBMSCs under aseptic conditions. This will be followed by obtaining optimum anaesthesia and reflection of a mucoperiosteal flap, followed by thorough debridement. Subsequently, the defect will be filled with PBMSCS + PRFM (SUPERCELL) in test sites and with PRFM in control sites. The surgical flaps which were elevated will be advanced coronally and sutured. A periodontal pack will be applied. All patients will be prescribed post-operative analgesics and antibiotics.  In the post-treatment phase, recall examinations and maintenance therapy will be scheduled at 1 week, 3, and 6 months, 1 year and 2 years postoperatively. Clinical photographs will be recorded at various stages in the period of the study. The data gathered from the study will be subjected to appropriate statistical analysis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy male and female subjects in the age group of 20-50 years, with gingival recession type 1 defect on at least 2 adjacent teeth, with no radiographic evidence of interdental bone loss.
  • Probing pocket depth ≤ 3 mm.
  • Adequate width of attached gingiva.

排除标准

  • Pregnant/lactating women.
  • Patients on drug therapy known to affect the number and function of platelets in the past 3 months.
  • Patients with abnormal platelet count or having disease affecting platelet count.
  • Patients with immunologic diseases.
  • Current and former smokers.
  • Patients having a history of periodontal therapy in the last 6 months.
  • Any other contraindications for periodontal surgery.

结局指标

主要结局

9. Gingival Thickness (GT)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

1. Plaque Index (PI): Silness and Loe (1964)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

2. Gingival Index (GI): Loe and Silness (1963)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

3. Vertical Component Of The Gingival Recession (VGR)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

8. Width of Keratinized Gingiva (KG)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

4. Horizontal Component Of The Gingival Recession (HGR)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

5. Probing Pocket Depth (PPD)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

6. Clinical Attachment Level (CAL)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

7. Width of Attached Gingiva (WAG)

时间窗: Baseline, 3 months, 6 months, 1 year, and 2 year.

次要结局

  • Root Coverage Esthetic Score (RCES): Cairo et. al. (2009)(6 months, 1 year, 2 year.)

研究者

发起方
DR JEEVIKA A DAS
申办方类型
Other [self]

研究点 (1)

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