Vit D and Post-extractive Bone Turnover (NCT06412705) | Clinical Trial Compass
CompletedNot Applicable
Vit D and Post-extractive Bone Turnover
Italy14 participantsStarted 2023-10-02
Plain-language summary
The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels.
Who can participate
Age range
18 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:
* Male or female adult (≥ 18 years old)
* Patients willing to participate and to attend the planned follow-up visits
Exclusion Criteria:
* Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
* History of leukocyte dysfunction and deficiencies
* History of neoplastic disease requiring the use of radiation or chemotherapy
* History of renal failure
* Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* History of uncontrolled endocrine disorders
* Alcoholism or any drug abuse
* History of immunodeficiency syndromes
* Smoker of 10 cig per day, cigar equivalents or tobacco chewers
* Conditions or circumstances which in the opinion of the investigator would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
* Mucosa disease such as erosive lichen planus
* Residual post-extraction site with intact bone walls
* History of local irradiation therapy
* Persistent intraoral 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
1
Dimensional alveolar bone changes
Timeframe: From extraction to implant insertion (4 months)
2
Evaluation of new formed bone tissue
Timeframe: Time of implant insertion: 4 months after extraction
3
Evaluation of Total Calcified Tissue (TCT)
Timeframe: Time of implant insertion: 4 months after extraction
4
Expression of Collagen A1
Timeframe: Time of implant insertion: 4 months after extraction
5
Expression of Osteocalcin
Timeframe: Time of implant insertion: 4 months after extraction
6
Expression of Osteopontin
Timeframe: Time of implant insertion: 4 months after extraction
7
Expression of Runx-2
Timeframe: Time of implant insertion: 4 months after extraction
8
Trial details
NCT IDNCT06412705
SponsorStudio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo