RecruitingNot Applicable

Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

Turkey (Türkiye)32 participantsStarted 2024-11-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The three-dimensional changes of free gingival graft

Timeframe: Baseline

The three-dimensional changes of free gingival graft.

Timeframe: 1st month

The three-dimensional changes of free gingival graft

Timeframe: 3rd month

The three-dimensional changes of free gingival graft

Timeframe: 6th month

Trial details

NCT IDNCT06399198

SponsorBiruni University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-10

Contact for this trial

Ayse E Selman

+905366393184 aselman@biruni.edu.tr

View on ClinicalTrials.gov More Insufficient Keratinized Gingiva trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.