By InvitationNot Applicable

Healing After Augmentation of Alveolar Ridge Using Collagen Membrane

Serbia90 participantsStarted 2025-03-07

Plain-language summary

One of the prerequisites for successful prosthetic implant therapy of patients is achieving the initial stability of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. Regenerative therapy of the horizontal dimension of the alveolar ridge simultaneously with the installation of implants is carried out using biocompatible materials; a basket of thin ones substitutes and collagen membranes. Clinical application of the collagen matrix to date has shown successful regeneration soft tissue in corrective surgery of the oral mucosa, by increasing the volume of the gingiva, approximately as effective as the application of a connective tissue graft from the palate. In the current literature, there is no data on the cellular effects of the regeneration of soft, a especially bone tissue, after the application of a membrane with cross-linked collagen type I, u regenerative therapy of fenestrations, dehiscence and buccal contour augmentations bone lamellae, simultaneously with implant placement. Also, tissue monitoring mechanisms of regeneration of soft and bone tissue, has not been shown in the literature so far controlled and systematized results using the Primescan digital program scans and software analysis of soft tissue regeneration parameters, as well as their own correlations with CBCT and clinical analysis.

Who can participate

Age range

18 Years – 65 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: * ASA I classification of health status, * Non-smokers or consumption of up to 10 cigarettes per day, * No signs of gingival inflammation, * Late installation of implants, * The possibility of achieving the primary stability of the implant, * The dimension of the residual alveolar ridge for implant placement ≥5 mm wide, height ≥12 mm, * Diagnosed fenestration, dehiscence of buccal bony lamella ≤3 mm in size and/or thickness of buccal bone lamella ≤1.5 mm, * Plaque index (PI) and gingival bleeding on provocation (KNP) \<15% and probing depth (DS) \<3 mm, * Preserved cemento-enamel border (CGG) without the presence of non-carious cervical lesions (NCL), or the presence of a defect in the root area up to 1mm deep with preserved CGG, * Preserved interjaw relationships. Exclusion Criteria: * Systemic acute administration of drugs up to 7 days before surgical intervention, * Systemic chronic administration of steroids or non-steroidal anti-inflammatory drugs, * History of oral surgical interventions in the last 4 months, * Poor oral hygiene, * Demonstrated hypersensitivity to collagen, * Pregnancy and breastfeeding, * Patient withdrawal from the research protocol in any evaluation period, * Patients who underwent standard augmentation of bone tissue with a substitute for bone and membrane, after implant installation, * Participation in clinical research in the last 6 months

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

Achived volume of the bone after implant placement and augmentation

Timeframe: 4 years

Trial details

NCT IDNCT06885983

SponsorUniversity of Belgrade

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

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