CompletedNot Applicable

Titanium-Reinforced PTFE Membranes for Bone Augmentation

Portugal14 participantsStarted 2022-04-01

Plain-language summary

This prospective comparative clinical study evaluated vertical and horizontal bone gain after guided bone regeneration using titanium-reinforced dense PTFE (TiR-dPTFE) membranes versus reinforced PTFE mesh (RPM) in patients requiring ridge augmentation prior to implant placement. Radiographic outcomes were assessed using CBCT at baseline, 9 months, and 12 months. Histological evaluation was performed in selected cases. Healing events and complications were recorded.

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: * Age ≥18 years * Partial or total edentulism requiring guided bone regeneration prior to implant placement * Presence of vertical alveolar bone defect \>3 mm * Full-mouth plaque score \<10% * Full-mouth bleeding on probing score \<10% * Ability to understand study procedures and provide written informed consent * Provision of written informed consent prior to enrollment Exclusion Criteria: * History of radiotherapy in the head and neck region * Smoking * Alcoholism or substance abuse * Untreated or active periodontitis * Pregnancy or breastfeeding * Participation in another clinical trial within the previous 30 days * Medical or behavioral conditions that could interfere with study participation or outcome evaluation, including poor compliance or unreliability

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

Vertical Bone Gain (VBG)

Timeframe: 9 months and 12 months after guided bone regeneration surgery

Trial details

NCT IDNCT07520903

SponsorUniversidade do Porto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Alveolar Ridge Deficiency trials