Vit D and Post-extractive Bone Turnover

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06412705
• Other study ID #: VITD-01
• Status: Completed
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Bone Resorption
• Bone Resorption
• Vitamin D Deficiency

Intervention

Procedure:
• Tooth 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.

Locations

Country	Name	City	State
Italy	Studi Odontoiatrici Luigi Canullo	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Country where clinical trial is conducted

Italy, 

Outcome

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