Three-dimensional Changes in Free Gingival Grafts Around Dental Implants
NCT ID: NCT06399198
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
32 participants
INTERVENTIONAL
2024-11-10
2025-07-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
smoker
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.
non-smoker
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Uncontrolled diabetes (HbA1c \> 7),
* Being pregnant or breastfeeding,
* Autoimmune and/or inflammatory diseases of the oral cavity,
* Active periodontal disease,
* Incorrectly positioned implants
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biruni University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ayse Ege SELMAN
Principle Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Biruni University
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ayşe Ege SELMAN
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
free gingival graft dimention
Identifier Type: -
Identifier Source: org_study_id