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Clinical Trials/NCT04042194
NCT04042194
Completed
N/A

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 site in 1 country30 target enrollmentJuly 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peri-implant Mucositis
Sponsor
Abant Izzet Baysal University
Enrollment
30
Locations
1
Primary Endpoint
Peri-implant Soft Tissue Thickness
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gulbahar

Assistant Professor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

  • 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,

Exclusion Criteria

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

Outcomes

Primary Outcomes

Peri-implant Soft Tissue Thickness

Time Frame: 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)\]

Secondary Outcomes

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

Study Sites (1)

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