Porcine Derma for Soft Tissue Augmentation Around Implants (NCT07436091) | Clinical Trial Compass
By InvitationNot Applicable
Porcine Derma for Soft Tissue Augmentation Around Implants
Portugal15 participantsStarted 2026-04-01
Plain-language summary
Brief description of the study objectives The present study aims to evaluate the effectiveness of the porcine-derived collagen matrix Derma OsteoBiol® for peri-implant soft tissue augmentation.
The objectives include:
Measuring changes in soft tissue thickness (in 3D) in the buccal region of the treated implants; Analyzing patient-reported outcomes (PROMs), namely pain and impact on oral health-related quality of life; Monitoring the stability of peri-implant tissues and aesthetic parameters over a 12-month period.
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 must have the ability to fully understand the nature of the proposed surgery, voluntarily consent to participate and signed the Informed Consent Form before any study related procedures are performed.
* Agree with data collection and analyses.
* Males or females who are a minimum of 18 years of age or older.
* Ability to comply with study-related procedures, including maintaining good oral hygiene and attending follow-up appointments.
* Implant placement at least 6 weeks prior to enrolment.
* There must be a need for soft tissue augmentation in an implant side.
* Implant located in the posterior areas of the maxilla or mandibula (molar or 2nd premolars).
* Basic periodontal examination (BPE) score must be less than 2.
* patients exhibiting KT width of \>2 mm at the buccal aspect of the implant.
Exclusion Criteria:
* • Patients who meet any of the following exclusion criteria are not eligible for inclusion in the study.
* General contraindications for dental and/or surgical treatment, including the use of anticoagulants.
* Presence of a vertical bone dehiscence greater than 3 mm at the implant site, as assessed at the time of soft tissue augmentation surgery.
* Heavy smoking habit, defined as consuming more than 10 cigarettes per day.
* Presence of active periodontal or peri-implant disease.
* Insulin-dependent diabetes.
* History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 year…
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.