Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around… (NCT05156294) | Clinical Trial Compass
UnknownPhase 3
Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants
Spain30 participantsStarted 2022-01-10
Plain-language summary
The main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and to reduce marginal bone loss during non-submerged implant placement, as compared with the standard protocol for implant placement. The test hypothesis is that placing an acellular dermal matrix membrane simultaneous to implant placement in the posterior mandible, will increase the soft tissue thickness and consequently reduce the marginal bone level changes.
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up
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:
* Systemically healthy
* Periodontally healthy or with stable treated periodontitis and good oral hygiene (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) ≤ 15%, measured at six sites per tooth)
* Need for one or two implants in the posterior mandible (maximum of three missing teeth).
* Enough bone availability to place an implant with a minimum diameter of 3.8 mm and at least 7 mm length.
* Non-smoker or smokers \< 10 cig/day (self-reported).
* Ability to understand the study procedures and to comply with them to the entire length of the study.
Exclusion Criteria:
* Subjects with uncontrolled systemic diseases (ASA type III).
* Subjects taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
* Pregnant or lactating women.
* Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs.
* History of cancer requiring radiotherapy or chemotherapy during the last 5 years.
* Local inflammation (including untreated periodontitis)
* Severe bruxism or clenching habits.
* Any kind of bone augmentation performed on the implant site, with a healing period \<6 months
* Less than 4 mm of keratinized mucosa
* Post-extraction sites with \<12 weeks of healing
* Lack of primary implant stability assessed intrasurgically.
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.