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

NCT04042194 | Completed

• 1 other identifier: 2018/68
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis; Peri-Implantitis; Thin Gingiva

Keywords

clinical research; Implant; Implantology; Prospective; Randomized controlled trial; Soft Tissue Grafting; Single-Tooth Implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Keratinised Tissue Width (KTW)

  Change from baseline keratinised tissue width at 3 months

Study Arms (2)

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.

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

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.

Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with CTG

Interventions

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.

Thickened 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.

Thickened with CTG

Eligibility Criteria

• Age: 29 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gülbahar Ustaoğlu

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: July 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)