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临床试验/NCT04042194
NCT04042194已完成不适用

Comparison of Connective Tissue Graft (CTG) and Titanium Prepared Platelet-Rich Fibrin (T-PRF) Inserted With a Double Layer Technique on Peri-Implant Soft Tissue Thickening: A Randomized Prospective Clinical Study

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Peri-implant Soft Tissue Thickness

研究概览

简要总结

The present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the CTG or T-PRF membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. The null hypothesis was that T-PRF used simultaneously with implant placement can be considered an alternative to CTG.

详细描述

Although connective tissue graft (CTG) is considered as the best technique for soft tissue augmentation, limited supply of donor tissue because of palatal vessels and nerves, and postoperative pain may require alternative methods.

The purpose of this study is to reduce the crestal bone resorption around the implant site by augmenting the Peri-Implant Soft Tissue with T-PRF (titanium prepared platelet-rich fibrin) or CTG and to compare the effectiveness of the two techniques.

Through simultaneous augmentation of the soft tissue by T-PRF or CTG, a total of 30 implants were implanted in 30 patients (12 males, 18 females) with a mean age of 38.4 years. In the test group, implants were placed in thin tissues and thickened with T- PRF membrane at the same time, while in the control group, implants were placed in thin tissues and thickened with CTG at the same time. During the surgery (T 0 ) and at postoperative 3 months (T 1 ), keratinised tissue width (KTW) and Peri-Implant soft tissue thickness (STT) were measured from three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), and over 1 mm of mucogingival junction (MGJ1).

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
29 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than 18 years,
  • thin gingiva biotype,
  • one missing tooth in the incisor, canine and premolar area and presence of two natural adjacent teeth
  • no bone increasing procedures prior to and during dental implant,

排除标准

  • history of a bleeding disorder or on anticoagulant therapy,
  • immunocompromised state and debilitating disease,
  • smoking and alcoholism,
  • poor oral hygiene,
  • diabetes.

研究组 & 干预措施

Thickened with CTG

Active Comparator

Following local anaesthesia, the measurement of soft tissue thickness at three points [1) occlusal part of the alveolar crest (OAC), 2) midbuccal mucosa level (MBML), 3) over 1 mm of mucogingival junction (MGJ1)] was performed with an endodontic spreader and digital caliber. Following the mid-crestal incision, the buccal flap was raised with double layer technique, while the lingual flap was left to enable direct visibility. The implant bed was drilled according to the manufacturer's protocol. The implants (BEGO Semados® RS/RSX implant system, Bremen, Germany) were placed at the bony crest. Right after the implant placement, the randomisation procedure was performed. In this group, the implants were placed in thin tissues, and CTG was inserted in the prepared mucoperiosteal flap at the facial site and secured with horizontal mattresses.

干预措施: Placement of Implants and Thickening Peri-Implant Mucosa with CTG (Procedure)

Thickened with T-PRF

Experimental

Following local anaesthesia, the measurement of soft tissue thickness at three points [1) occlusal part of the alveolar crest (OAC), 2) midbuccal mucosa level (MBML), 3) over 1 mm of mucogingival junction (MGJ1)] was performed with an endodontic spreader and digital caliber. Following the mid-crestal incision, the buccal flap was raised with double layer technique, while the lingual flap was left to enable direct visibility. The implant bed was drilled according to the manufacturer's protocol. The implants (BEGO Semados® RS/RSX implant system, Bremen, Germany) were placed at the bony crest. Right after the implant placement, the randomisation procedure was performed. In this group, the implants were placed in thin tissues, and T-PRF was inserted in the prepared mucoperiosteal flap at the facial site and secured with horizontal mattresses.

干预措施: Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF (Procedure)

结局指标

主要结局

Peri-implant Soft Tissue Thickness

时间窗: Change from baseline soft tissue thickness at 3 months

The measurement of soft tissue thickness at three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), over 1 mm of mucogingival junction (MGJ1)\]

次要结局

  • Keratinised Tissue Width (KTW)(Change from baseline keratinised tissue width at 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulbahar

Assistant Professor

Abant Izzet Baysal University

研究点 (1)

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