Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
- Conditions
- Insufficient Keratinized Gingiva
- Interventions
- Procedure: Free gingival graft
- Registration Number
- NCT06399198
- Lead Sponsor
- Biruni University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Free gingival grafting to the area where implants were previously implanted Free gingival graft - Free gingival grafting before implant surgery Free gingival graft -
- Primary Outcome Measures
Name Time Method The three-dimensional changes of free gingival graft 6th month An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft. 1st month An intraoral digital scanner will be used to assess the graft's dimensions alterations.
- Secondary Outcome Measures
Name Time Method Bleeding on probing 6th month Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (\~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.
Keratinized mucosa width 6th month The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Wound healing 6th month Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.
Probing depth 6th month Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Gingival Index 6th month 0: normal gingiva
mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleedingPatient reported outcomes 10th day After the surgical procedure, patients will be asked to complete a form consisting of 4 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days), (3) number of analgesic tablets taken, and (4) willingness to undergo the same surgery again (yes/no).
Plaque index 6th month 0: Absence of microbial plaque
Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque
Trial Locations
- Locations (1)
Biruni University
🇹🇷Istanbul, Turkey