CompletedNot Applicable

Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability

Lithuania40 participantsStarted 2018-01-01

Plain-language summary

This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are.

Who can participate

Age range

18 Years – 75 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: * Male and female patients between 18-75 years old. * Physical and psychological capacity to undergo implant therapy (ASA I or II). * Fully healed single mandibular posterior treatment sites (premolars or molars) being edentulous for at least 3 months. * Minimum of 6 mm width and 8 mm height native bone ridge. * No requirement for concomitant or a history of regenerative treatments. * Minimum of 4mm keratinized mucosa at the implant site (2 mm buccal and 2mm lingual). * Healthy non-inflamed keratinized soft tissues with a maximum soft tissue thickness height of 2 mm measured at crestal buccal and lingual aspects. * Periodontally healthy by fulfilling all of the following criteria: Full-mouth bleeding score (FMBS) \< 20%, Full-mouth plaque score (FMPS) \< 15%, Community Periodontal Index of Treatment Needs (CPITN) \< 2. Exclusion Criteria: * Patients with a history of periodontitis. * Poor oral hygiene after Oral Hygiene Instructions (OHI). * Pregnant or lactating. * Uncontrolled concomitant medical diseases, e.g., diabetes. * Receiving or having received pharmacological treatment affecting wound healing within 3 months prior to the study-related intervention.

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.

What they're measuring

Crestal Bone Levels

Timeframe: Baseline - 1year follow up

Trial details

NCT IDNCT06302387

SponsorHarvard Medical School (HMS and HSDM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-01

View on ClinicalTrials.gov More Soft Tissue Augmentation trials