Histological Analysis of Osteogenic Potential of Biphasic Calcium Phosphate (NCT06020092) | Clinical Trial Compass
CompletedPhase 4
Histological Analysis of Osteogenic Potential of Biphasic Calcium Phosphate
Croatia36 participantsStarted 2021-07-31
Plain-language summary
Bone healing after tooth extraction may be affected by defects in the buccal wall of the alveolus, such as fenestrations and dehiscences. Therefore, it is advisable to perform a surgical procedure such as guided bone regeneration after tooth extractions. Different biomaterials are used for this purpose. The aim of this study is to investigate the qualitative and quantitative histological changes in human biopsies taken after 6 months of healing of extraction sockets with buccal wall defects. For this purpose, the defects of 36 patients (18 per group) will be augmented with injectable biphasic calcium phosphate (I-BCP) or bovine xenograft (BX) after extraction. After six months of healing, bone biopsies will be taken and processed to the qualitative and quantitative histological analysis.
Who can participate
Age range
18 Years – 60 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 between 18 and 60 years
* patients requires to have at least one tooth predisposed to extraction
* intact physical and mental health
* patient must understand the study protocol
* patient must sign an informed consent.
* the presence of a buccal bone defect such as fenestration or dehiscence.
Exclusion Criteria:
* patients will be excluded from the study if they had at least one of the absolute contraindications to implant prosthetic therapy
* following systemic diseases: uncontrolled diabetes, osteoporosis and osteopenia, and vitamin D deficiency
* bisphosphonate therapy
* glucocorticoid therapy
* hypothyroidism
* uncontrolled cardiovascular disease (hypertension, coronary artery disease, congestive heart failure)
* pregnant or lactating women
* following local factors: use of tobacco products (up to 10 cigarettes per day) and poor oral hygiene
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
Percentage of the newly formed bone, soft tissue and residual biomaterial in bone biopsies harvested 6 months after bone augmentation
Timeframe: Up to 8 months
Trial details
NCT IDNCT06020092
SponsorJosip Juraj Strossmayer University of Osijek