Clinical trial NCT06412705: Vit D and Post-extractive Bone Turnover
Official title: The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Alveolar Bone Loss
Alveolar Bone Resorption
Keywords: Dental Implants, Alveolar Bone Loss, Alveolar Process
Lead sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Dimensional alveolar bone changes
timeFrame: From extraction to implant insertion (4 months)
measure: Evaluation of new formed bone tissue
timeFrame: Time of implant insertion: 4 months after extraction
measure: Evaluation of Total Calcified Tissue (TCT)
timeFrame: Time of implant insertion: 4 months after extraction
measure: Expression of Collagen A1
timeFrame: Time of implant insertion: 4 months after extraction
measure: Expression of Osteocalcin
timeFrame: Time of implant insertion: 4 months after extraction
measure: Expression of Osteopontin
timeFrame: Time of implant insertion: 4 months after extraction
measure: Expression of Runx-2
timeFrame: Time of implant insertion: 4 months after extraction
measure: Evaluation of Implant Stability Quotient (ISQ)
timeFrame: Time of implant insertion: 4 months after extraction
measure: Evaluation of Implant Torque Value (ITV)
timeFrame: Time of implant insertion: 4 months after extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Studi Odontoiatrici Luigi Canullo
state: RM
Study officials:
affiliation: Studi Odontoiatrici Luigi Canullo
name: Luigi Canullo
role: PRINCIPAL_INVESTIGATOR
References: