CompletedNot Applicable

Cortical Lamina for Alveolar Ridge Preservation

Cuba40 participantsStarted 2024-04-01

Plain-language summary

This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated flap and buccal bone plate following tooth extraction for preserving alveolar ridge dimensions. Forty patients will be randomly assigned to either the test group (lamina placement) or control (no intervention). Changes in ridge width and height will be assessed using CBCT and 3D digital models after six months.

Who can participate

Age range

21 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: * Presence of a tooth indicated for extraction (maxillary incisors, canines, or premolars in either jaw). * Age ≥ 21 years. * Good general health with no contraindications for oral surgery. * Non-pregnant individuals. * Willingness to participate and sign written informed consent. Exclusion Criteria: * Uncontrolled systemic disease (e.g., diabetes mellitus, hypertension). * History of chemotherapy or radiotherapy. * Current smokers of more than 10 cigarettes per day. * Sites previously treated with regenerative or augmentation procedures. * Poor oral hygiene or active periodontal infection.

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 Alveolar Ridge Width and Height

Timeframe: Baseline (immediately post-extraction) to 6 months after extraction

Trial details

NCT IDNCT07231874

SponsorARDEC Academy

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Tooth Extraction trials