Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

Official title

Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

Overview

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.

Interventions

• Procedure Free gingival graft
  After adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface.

Primary outcome measures

• The three-dimensional changes of free gingival graft [Time frame: Baseline]
• The three-dimensional changes of free gingival graft. [Time frame: 1st month]
• The three-dimensional changes of free gingival graft [Time frame: 3rd month]
• The three-dimensional changes of free gingival graft [Time frame: 6th month]

Secondary outcome measures (12)

• Plaque index [Time frame: Baseline]
• Plaque index [Time frame: 1st month]
• Plaque index [Time frame: 3rd month]
• Plaque index [Time frame: 6th month]
• Gingival Index [Time frame: Baseline (prior to therapy)]
• Gingival Index [Time frame: 1st month]
• Gingival Index [Time frame: 3rd month]
• Gingival Index [Time frame: 6th month]
• Bleeding on probing [Time frame: Baseline]
• Bleeding on probing [Time frame: 1st month]
• Bleeding on probing [Time frame: 3rd month]
• Bleeding on probing [Time frame: 6th month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Turkey (Türkiye) · 1 center

• Biruni University — Istanbul

Identifiers

NCT: NCT06399198 · free gingival graft dimention

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗