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Vit D and Post-extractive Bone Turnover

The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06412705
Enrollment
14
Registered
2024-05-14
Start date
2023-10-02
Completion date
2024-04-30
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss, Alveolar Bone Resorption, Vitamin D Deficiency

Keywords

Dental Implants, Alveolar Bone Loss, Alveolar Process

Brief 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.

Detailed description

The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT).

Interventions

PROCEDURETooth extraction, guided bone regeneration and dental implant

The arm received tooth extraction and contextual guided bone regeneration. After 4 months, a dental implant was inserted.

Sponsors

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dimensional alveolar bone changesFrom extraction to implant insertion (4 months)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.
Evaluation of new formed bone tissueTime of implant insertion: 4 months after extractionEvaluation of new formed bone tissue performed by histomorphometric methods.
Evaluation of Total Calcified Tissue (TCT)Time of implant insertion: 4 months after extractionEvaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods.
Expression of Collagen A1Time of implant insertion: 4 months after extractionquantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of OsteocalcinTime of implant insertion: 4 months after extractionquantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of OsteopontinTime of implant insertion: 4 months after extractionquantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of Runx-2Time of implant insertion: 4 months after extractionquantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Evaluation of Implant Stability Quotient (ISQ)Time of implant insertion: 4 months after extractionEvaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with Osstell system (W&H)
Evaluation of Implant Torque Value (ITV)Time of implant insertion: 4 months after extractionEvaluation of Implant Torque Value at the implant insertion performed with the surgery implant device.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026