3D Digital Assessment of Soft Tissue Changes After Modified FGG (NCT07409558) | Clinical Trial Compass
RecruitingNot Applicable
3D Digital Assessment of Soft Tissue Changes After Modified FGG
Turkey (Türkiye)34 participantsStarted 2025-01-04
Plain-language summary
The aim of this randomized controlled clinical trial is to evaluate the effects of conventional free gingival graft (FGG) and modified free gingival graft (ModFGG) techniques on soft tissue thickness, volumetric change, and creeping attachment in mandibular incisors using three-dimensional direct digital analysis. The study will include a total of 34 systemically healthy, non-smoking individuals with localized Cairo Class II gingival recession. Participants will be randomly assigned to the FGG (control) and ModFGG (test) groups. Clinical measurements will be performed before surgery and at 1, 3, and 6 months post-surgery. Soft tissue thickness and volumetric changes will be analyzed three-dimensionally by overlaying digital models obtained with an intraoral scanner. Gingival recession depth, keratinized tissue height, and creeping attachment will also be assessed. The aim is to provide clinical evidence regarding the effects of the modified free gingival graft technique on soft tissue stability and volumetric gains.
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:
* Age 18 years or older
* Systemically healthy individuals
* Non-smokers
* Presence of localized Cairo Class II gingival recession with a vertical recession depth of ≥3 mm on the buccal surfaces of mandibular incisors
* Probing pocket depth of ≤3 mm at the tooth/teeth to be treated
* No tooth mobility (mobility grade ≤1)
* Absence of cervical composite restorations or non-carious cervical lesions
* Presence of a shallow vestibule (\<5 mm)
Exclusion Criteria:
* Pregnancy or lactation
* Untreated periodontal disease
* Presence of parafunctional habits
* Poor oral hygiene, defined as a full-mouth plaque score \>20%
* Malpositioned, rotated, or crowded teeth in the buccal position
* Known systemic diseases (e.g., acquired immunodeficiency syndrome, diabetes mellitus)
* Any condition or medication that may affect gingival wound healing
* ASA physical status classification III or higher
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
1
Soft Tissue Volumetric Changes
Timeframe: Baseline, 1 month, 3 months, and 6 months