Vitamin D Deficiency Clinical Trial
Official title:
The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial
NCT number | NCT06412705 |
Other study ID # | VITD-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2023 |
Est. completion date | April 30, 2024 |
Verified date | May 2024 |
Source | Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Studi Odontoiatrici Luigi Canullo | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dimensional alveolar bone changes | Volumetrical changes of alveolar bone after tooth extraction measured by superimposition of two intraoral scans. The first was registered before the extraction of the tooth. The second was registered after 4 months (before inserting implant). The parameter used to measure the dimensional alveolar bone change is called "Integrated Distance" and it is expressed in mm3. | From extraction to implant insertion (4 months) | |
Primary | Evaluation of new formed bone tissue | Evaluation of new formed bone tissue performed by histomorphometric methods. | Time of implant insertion: 4 months after extraction | |
Primary | Evaluation of Total Calcified Tissue (TCT) | Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods. | Time of implant insertion: 4 months after extraction | |
Primary | Expression of Collagen A1 | quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. | Time of implant insertion: 4 months after extraction | |
Primary | Expression of Osteocalcin | quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. | Time of implant insertion: 4 months after extraction | |
Primary | Expression of Osteopontin | quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. | Time of implant insertion: 4 months after extraction | |
Primary | Expression of Runx-2 | quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ. | Time of implant insertion: 4 months after extraction | |
Primary | Evaluation of Implant Stability Quotient (ISQ) | Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W&H) | Time of implant insertion: 4 months after extraction | |
Primary | Evaluation of Implant Torque Value (ITV) | Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device. | Time of implant insertion: 4 months after extraction |
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