Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft (NCT07667855) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peri-implant Soft Tissue Augmentation Using Microneedling With i-PRF vs. Connective Tissue Graft
Lebanon24 participantsStarted 2026-06-26
Plain-language summary
This randomized controlled clinical trial aims to evaluate a minimally invasive technique for peri-implant soft tissue augmentation using microneedling combined with injectable platelet-rich fibrin (i-PRF) compared with the current gold-standard connective tissue graft (CTG). Patients with thin peri-implant soft tissue requiring implant second-stage surgery in the esthetic zone will be randomly assigned to receive either CTG harvested from the palate or a series of microneedling and i-PRF treatments. Clinical outcomes including mucosal thickness, keratinized tissue width, peri-implant health parameters, volumetric soft tissue changes, esthetic outcomes, and patient-reported measures of pain and satisfaction will be evaluated during follow-up. The study aims to determine whether microneedling with i-PRF can provide comparable soft tissue augmentation while reducing patient morbidity associated with connective tissue graft harvesting.
Who can participate
Age range
18 Years – 65 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:
* Systemically healthy adults (Between 18 and 65) with one or more dental implants requiring second-stage surgery in the esthetic zone (Anteriors and Premolars).
* Thin soft tissue phenotype: mucosal thickness or KTW \<2 mm buccally.
* Stable osseointegrated implant, adequate restorative space, and healthy adjacent teeth.
* Good oral hygiene (PI ≤10%), with peri-implant maintenance.
* Signed consent + willingness for 1-year follow-up.
Exclusion Criteria:
* Heavy smokers (≥10 cig/day); light smokers only if reduced.
* Systemic/healing issues: uncontrolled diabetes, immunocompromise, bleeding disorders, anticoagulants, steroids.
* Pregnancy or breastfeeding.
* Active infection (periodontal or peri-implant).
* No residual keratinized mucosa on buccal side.
* Previous graft/augmentation at the site or recent surgery (\<6 months).
* Allergies to anesthetics/materials.
* Non-compliance with instructions or follow-up.
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.