Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers (NCT06190860) | Clinical Trial Compass
UnknownNot Applicable
Platelet Rich Fibrin Treatment for the Alveolar Ridge Preservation in Smokers
Chile16 participantsStarted 2022-05-29
Plain-language summary
Bone healing is affected by smoking, particularly healing of extraction sockets, showing deficiencies in vertical and horizontal bone dimensions compared to the healing of non-smokers. Several approaches have been made to stimulate.
Bone wound healing, including human autologous blood-derived fractions. One of these fractions is the leukocyte platelet-rich fibrin (L-PRF).
L-PRF has been evidenced as potentially beneficial in promoting bone defect filling in alveolar bone and socket preservation in non-smokers. However, scarce evidence is related to this beneficial effect in smokers.
This clinical trial aims to study and compare the in vivo effects of L-PRF during bone wound healing and regeneration in smokers.
The main question is:
Has the L-PRF a beneficial effect during alveolar ridge preservation in smokers? After consent, participants with tooth extraction indications and implant rehabilitation treatment will be enrolled. After randomization, participants will be assigned to an experimental group treated with L-PRF plugs and membranes or a control group (physiological healing).
Participants will receive two interventions:
* First intervention: Tooth extraction, intraoral scan, and Cone Beam Computed Tomography in the treated zone.
* Second intervention (4 months after first intervention): intraoral scan and Cone Beam Computed Tomography in the treated zone
Who can participate
Age range
20 Years – 70 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:
Smokers (at least five cigarettes/day) have had the habit for at least one year.
* treatment plan that includes the indication of extraction of a single, double-rooted, or multi-rooted tooth and prosthetic rehabilitation with osseointegrated implants
* Patients with controlled systemic pathologies (hypertension, diabetes, hypercholesterolemia).
* With alveolar bone support of at least 50% and whose indication is delayed implant placement at least four months after extraction.
* Periapical lesions of no more than 5 mm diameter.
Exclusion Criteria:
* patients taking immunosuppressive or anticoagulant drugs
* pregnant
* users of removable prostheses
* Individuals with altered values of platelet count or coagulation parameters.
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
1
Alveolar ridge changes
Timeframe: inmediately after tooth extraction and after four months