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临床试验/CTRI/2017/10/010136
CTRI/2017/10/010136已完成不适用

Treatment Of Gingival Recession Defects With Autologous Platelet Rich Fibrin (PRF) And Autogenous Connective Tissue Graft (CTG) In Conjunction With Coronally Advanced Flap Using Microsurgical Technique: A Comparative Clinical Study

Saraswati Dental College Lucknow1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年12月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Hypersensitivity score,

研究概览

简要总结

Purpose: To evaluate autologous Platelet Rich Fibrin (PRF) and autogenous Connective Tissue Graft (CTG) in gingival recession defects in conjunction with coronally advanced flap (CAF) using microsurgical technique.

Materials and Methods: Forty-five class I and II recession defects were randomly equally (n=15) divided into three groups: Group I sites treated with CAF with PRF; Group II sites treated with CAF with CTG and Group III sites treated with CAF alone using microsurgical approach in 36 patients.  Parameters recorded were vertical (VGR) and horizontal gingival recession (HGR), % Complete root coverage (CRC), Patient comfort score (PCS), Patient esthetic score (PES) and Hypersensitivity score (HS) at 10 days, 3 months and 6 months.

Results: CAF surgery alone and in combination with PRF or CTG, are effective  procedures to cover denuded roots with mean VGR values of 1.26±0.70 mm (74.4%),  1.26±0.59 mm (58%) and 1.06±0.79 mm (53.3%) for Group I, II and III. In terms of complete root coverage (CRC) achieved at 6 months, results showed that 100% CRC was obtained in 60 % sites of Group I, 20 % sites of Group II and 27% in Group III. Patient response and acceptance for surgical treatment modality in terms of PCS and PES was highest for Group I (PRF and CAF) followed by Group III, and Group II; and there was decrease in hypersensitivity score (HS) for Group I (PRF and CAF) while no significant changes in HS scores were observed for Group II and Group III.At the end of six months follow-up there was significant increase in gingival thickness measurements using transgingival probing in Group II, whereas non-significant changes were observed in Group 1and Group III.

Conclusions: Long term multicentric randomized controlled clinical study may be necessary to evaluate the clinical outcome for autologous PRF in comparison to CTG and CAF alone.

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 40.00 Year(s)(—)
性别
All

入选标准

  • Patients (1) having at least one tooth in maxillary anterior teeth region with Millers Class I or Class II labial gingival recession defect; (2) in good general health (ASA-I) with no contraindications for periodontal surgery; (3) not using antibiotics, corticosteroids, chemotherapeutics, immunomodulators, or others that modify the results of periodontal therapy during the last six months; (4) selected teeth must be free of endodontic treatment, buccal or interproximal restoration; (5) who have not undergone any periodontal treatment in the preceding six months of initial examination.

排除标准

  • 未提供

结局指标

主要结局

Hypersensitivity score,

时间窗: At 3 months and 6 months post-intervention

Probing pocket depth,

时间窗: At 3 months and 6 months post-intervention

Clinical attachment level,

时间窗: At 3 months and 6 months post-intervention

Horizontal gingival recession,

时间窗: At 3 months and 6 months post-intervention

at 3 months and 6 months

时间窗: At 3 months and 6 months post-intervention

Vertical gingival recession,

时间窗: At 3 months and 6 months post-intervention

Patient esthetic score,

时间窗: At 3 months and 6 months post-intervention

Patient comfort score,

时间窗: At 3 months and 6 months post-intervention

次要结局

  • Gingival thickness(Patient esthetic score,)

研究者

发起方
Saraswati Dental College Lucknow
申办方类型
Other [Infrastructural support by Institution]

研究点 (1)

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