Peri-implant Soft Tissue Changes at Small Buccal Dehiscences (NCT07501715) | Clinical Trial Compass
CompletedNot Applicable
Peri-implant Soft Tissue Changes at Small Buccal Dehiscences
Italy44 participantsStarted 2023-09-05
Plain-language summary
This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (\<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or guided bone regeneration and evaluated at 3 months after surgery and at 12 months of follow up after crown placement
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:
* Adults ≥18 years of age
* Patients requiring a single dental implant in a healed site in the posterior region (premolar or molar areas)
* Presence of a buccal bone dehiscence defect at implant placement, defined as a vertical defect of the buccal bone plate ≥1 mm and ≤3 mm measured from the implant shoulder after implant insertion
* Adequate residual bone to allow implant placement with primary stability (insertion torque ≥25 Ncm or ISQ ≥60)
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
* Patients able to understand and sign informed consent
* Patients willing to comply with study procedures and follow-up visits
Exclusion Criteria:
* Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, HbA1c \>7.5%)
* Immunocompromised patients
* History of radiotherapy in the head and neck region
* Use of medications affecting bone metabolism (e.g., bisphosphonates, denosumab)
* Pregnancy or lactation
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.