Osteoimplant and Bone Healing (NCT06664060) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Osteoimplant and Bone Healing
60 participantsStarted 2025-01-07
Plain-language summary
In view of the above and the possible improvements in terms of postoperative morbidity and tissue repair in oral surgery, this study is justified, the general objective of which would be:
'To evaluate the efficacy of perioperative oral administration of two nutritional supplements based on vitamins and antioxidants (Osteoimplant Complex® and Osteoimplant®), using mandibular third molar surgery as a study model, assessing postoperative symptomatology and bone density'.
The null hypothesis of this study is: 1) the administration of the perioperative nutritional complex (Osteoimplant Complex® and Osteoimplant®) did not improve postoperative symptoms and 2) neither did it increase bone density after lower third molar extraction.
Who can participate
Age range
18 Years – 40 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:
* Patients presenting both lower third molars.
* Adult patients between 18 and 40 years of age.
* Anaesthetic risk ASA I-II (American Society of Anaesthesiologists classification) \[14\].
* Absence of drug or food allergies that could compromise our study (e.g. egg).
* Signed informed consent.
Exclusion Criteria:
* Age not between 18-40 years.
* Pregnant or breastfeeding women.
* Presenting decompensated metabolic disease.
* Poor periodontal status (≥10% plaque index and bleeding index).
* Patients who have undergone radiotherapy in the last five years.
* Patients who will not comply with the study guidelines.
* Unsigned informed consent.
* History of allergy to any study medication or related drugs (e.g. egg).
* Patients with a history of renal colic.
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
diensional changes
Timeframe: From the extraction (T0) to 8 weeks after (T1) extraction
Trial details
NCT IDNCT06664060
SponsorUniversidad de Granada
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2025-12-31
Contact for this trial
FRANCISCO JAVIER MANZANO-MORENO MANZANO-MORENO, PhD