Keratinized Tissue Gain Following Apically Positioned Flap with and Without Free Gingival Graft S… (NCT06694623) | Clinical Trial Compass
CompletedNot Applicable
Keratinized Tissue Gain Following Apically Positioned Flap with and Without Free Gingival Graft Strip
Serbia17 participantsStarted 2023-03-01
Plain-language summary
In non-implant edentulous patients reduction of height and width of residual alveolar ridge and reduced attached KT compromise the denture-bearing area unambiguously leading to decrease in full denture stability and retention. Furthermore, in implant edentulous patients insufficient KT is associated with increased plaque accumulation, tissue inflammation, soft tissue recession, marginal bone loss and increased prevalence of peri-implantitis. The present study aimed to evaluate keratinized tissue gain and the wound contraction rate between apically positioned flap without and with free gingival graft strip over a 6-month follow up period.
This research was designed as split mouth controlled clinical study included 17 patients having edentulous upper jaw with reduced width of keratinized tissue ( ≤ 4mm measured from middle of the crest to the buccal mucogingival junction or ≤ 2mm from occluso-buccal edge of the alveolar ridge to the mucogingival junction). In each patient, both surgical techniques, apically positioned flap without and with free gingival graft strip, were applied simultaneously. The change of keratinized tissue width and wound contraction rate were measured 30, 60 , 90 and 180 days after surgery
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:
* patients with edentulous upper jaws which are not able to wear full upper denture owing to compromise retention and stability being 18 years old or older,
* patients with reduced width of keratinized tissue (≤ 4mm) measured from middle of the crest to the buccal mucogingival junction ( the distance from occluso-buccal edge of the alveolar ridge to the mucogingival junction ≤ 2mm), - patients who belong to ASA1 or ASA2, according to the American Academy to Anesthesiology
* patients who do not suffer from any systemic disease affecting wound healing,
* patients which are able to provide a signed informed consent and are able to comply with determined follow-up time points.
Exclusion Criteria:
* patient is a heavy smoker (more than 10 cigarettes per day),
* patients with history of malignancy, radiotherapy or chemotherapy within the 5 years,
* pregnant or nursing patients,
* patients who are taking medications which have an effect on mucosal healing in general (steroids, non-steroidal anti-inflammatory drugs taken in high doses and in long term, bisphosphonates).
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.