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

Primary Purpose

Peri-implant Mucositis, Peri-Implantitis, Thin Gingiva

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF
Placement of Implants and Thickening Peri-Implant Mucosa with CTG
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring clinical research, Implant, Implantology, Prospective, Randomized controlled trial, Soft Tissue Grafting, Single-Tooth Implants

Eligibility Criteria

29 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bolu Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thickened with T-PRF

Thickened with CTG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)]

Secondary Outcome Measures

Keratinised Tissue Width (KTW)
The measurement of the keratinised tissue width between the cover screw and the mucogingival junction.

Full Information

First Posted
July 30, 2019
Last Updated
July 31, 2019
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04042194
Brief Title
Comparison of CTG and T-PRF on Peri-Implant Soft Tissue
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis, Peri-Implantitis, Thin Gingiva
Keywords
clinical research, Implant, Implantology, Prospective, Randomized controlled trial, Soft Tissue Grafting, Single-Tooth Implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thickened with T-PRF
Arm Type
Experimental
Arm Description
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.
Arm Title
Thickened with CTG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placement of Implants and Thickening Peri-Implant Mucosa with CTG
Intervention Description
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 Outcome Measure Information:
Title
Peri-implant Soft Tissue Thickness
Description
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)]
Time Frame
Change from baseline soft tissue thickness at 3 months
Secondary Outcome Measure Information:
Title
Keratinised Tissue Width (KTW)
Description
The measurement of the keratinised tissue width between the cover screw and the mucogingival junction.
Time Frame
Change from baseline keratinised tissue width at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülbahar Ustaoğlu
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolu Abant Izzet Baysal University
City
Bolu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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