CompletedNot Applicable

Soft Tissue Augmentation Around Dental Implants

Russia84 participantsStarted 2021-10-01

Plain-language summary

The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics. The main questions it aims to answer: Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials? Researchers will compare: Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue Participants will: Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly) Attend clinic visits for follow-up examinations and assessments: * Before surgery * 3 months after surgery * 6 months after surgery Undergo additional examinations: * 3D intraoral scanning to assess changes in tissue volume * Cone-beam computed tomography (CBCT) to measure gum thickness * Polarized-light photography to evaluate gum color * Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition

Who can participate

Age range

21 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: * Age between 21 and 75 years * Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth) * Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm * Signed voluntary informed consent for treatment and research participation * Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery * Adequate oral hygiene and commitment to maintain it throughout the study period Exclusion Criteria: * Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease) * Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids * History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment * Need for concurrent bone grafting or immediate implant placement following tooth extraction * Active periodontal disease or untreated oral infections at the time of surgery * Heavy smoking (\>10 cigarettes/day) or inability to abstain from smoking during the healing period * Pregnancy or lactation * Known allergy to collagen, porcine/bovine products, or materials used in the study (sutures, anesthetics) * Participation in another clinical trial within 30 days prior to enrollment * Refusal to participate in any stage of the study or inability to comply with study procedures * Psychological or social conditions that, in the investigator's judgment, may compro…

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

Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation

Timeframe: Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery

Trial details

NCT IDNCT07605286

SponsorAndrey Vasilyev

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Peri-implant Soft Tissue Augmentation trials