Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

Biruni University

Status: Enrolling

Conditions: Insufficient Keratinized Gingiva

Treatments: Procedure: Free gingival graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06399198

free gingival graft dimention

Details and patient eligibility

About

The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:

Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?

Our study consists of 2 groups:

The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).

The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).

Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Periodontal and peri-implant tissue health
• Good oral hygiene (plaque accumulation <20%)
• Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
• No systemic disease and medication use that may affect soft tissue healing.
• Volunteering to participate in the study

Exclusion criteria

• Systemic disease that is a contraindication to the surgical procedure,
• Uncontrolled diabetes (HbA1c > 7),
• Being pregnant or breastfeeding,
• Autoimmune and/or inflammatory diseases of the oral cavity,
• Active periodontal disease,
• Incorrectly positioned implants

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

smoker

Experimental group

Treatment:

Procedure: Free gingival graft

non-smoker

Experimental group

Treatment:

Procedure: Free gingival graft