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NCT Number: NCT04042194

Comparison of CTG and T-PRF on Peri-Implant Soft Tissue

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.

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Key information

Conditions

Peri-implant Mucositis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases Thin Gingiva

Age range

29 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF

Procedure

A total of 40 ml blood sample was collected from the antecubital vein of the patients' right or left arms with 10 ml injectors. 40 ml blood was transferred to a grade-IV titanium tube for the T-PRF group. The titanium tubes containing the blood samples were instantly centrifuged in a tabletop centrifuge at room temperature. The blood samples of the T-PRF group were centrifuged clockwise at 2700 RPM for 20 minutes. Subsequent to the centrifugation process, the clots of the T-PRF group were removed from the tubes with sterile tweezers, separated from the RBC base with scissors, and left for over 20 minutes on sterile woven gauze to release the serum slowly from the collected clots. The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with T-PRF.

Placement of Implants and Thickening Peri-Implant Mucosa with CTG

Procedure

The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with CTG. Autogenous connective tissue graft was harvested according to a single incision technique.

Primary outcomes

  1. 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

  1. Keratinised Tissue Width (KTW)

    Time frame: Change from baseline keratinised tissue width at 3 months

    The measurement of the keratinised tissue width between the cover screw and the mucogingival junction.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2019
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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