Clinical trial NCT04042194: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Peri-Implantitis
Thin Gingiva
Keywords: clinical research
Implant
Implantology
Prospective
Randomized controlled trial
Soft Tissue Grafting
Single-Tooth Implants
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 29
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Peri-implant Soft Tissue Thickness
timeFrame: Change from baseline soft tissue thickness at 3 months
Secondary outcomes:
measure: Keratinised Tissue Width (KTW)
timeFrame: Change from baseline keratinised tissue width at 3 months
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Gülbahar Ustaoğlu
role: PRINCIPAL_INVESTIGATOR
References: