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

Peri-Implantitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042194
• Other study ID #: 2018/68
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis
• Thin Gingiva

Intervention

Procedure:
• Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF
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
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.

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-implant Soft Tissue Thickness	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)]	Change from baseline soft tissue thickness at 3 months
Secondary	Keratinised Tissue Width (KTW)	The measurement of the keratinised tissue width between the cover screw and the mucogingival junction.	Change from baseline keratinised tissue width at 3 months