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

Not Applicable

Completed

• Conditions: Peri-Implantitis; Peri-implant Mucositis; Thin Gingiva
• Interventions: Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with CTG; Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF

• Registration Number: NCT04042194
• Lead Sponsor: Abant Izzet Baysal University

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).

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-04-01
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-31
• Last Update Submitted: 2019-07-31
• Study First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thickened with CTG	Placement of Implants and Thickening Peri-Implant Mucosa with CTG	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.
Thickened with T-PRF	Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF	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.

Primary Outcome Measures

Name	Time	Method
Peri-implant Soft Tissue Thickness	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 Outcome Measures

Name	Time	Method
Keratinised Tissue Width (KTW)	Change from baseline keratinised tissue width at 3 months	The measurement of the keratinised tissue width between the cover screw and the mucogingival junction.

Trial Locations

Locations (1)

Bolu Abant Izzet Baysal University; 🇹🇷 Bolu, Turkey