Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (NCT06338241) | Clinical Trial Compass
UnknownPhase 4
Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model
Spain30 participantsStarted 2024-03-02
Plain-language summary
The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.
Who can participate
Age range
18 Years – 50 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:
* Participants must be of legal age.
* Participants must provide informed consent for participation in the study.
* Participants must require extraction of both impacted mandibular third molars.
* Both impacted molars must exhibit a similar level of complexity for extraction.
* Participants must have no history of infection in the impacted molars prior to extraction.
* Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification).
Exclusion Criteria:
* Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
* Participants currently receiving medications contraindicated for dental extractions.
* Participants under the age of legal consent.
* Participants who have undergone head and neck radiotherapy within the past 18 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
1
Bone Regeneration_Reduction in radiolucent volume
Timeframe: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
2
Bone Regeneration_bone volume
Timeframe: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
3
Bone Regeneration_bone density
Timeframe: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
4
Bone Regeneration_Fractal dimension
Timeframe: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months