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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Alveolar Bone Loss; Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Tooth extraction, guided bone regeneration and dental implant

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).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00100
      • Studi Odontoiatrici Luigi Canullo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tooth extraction and bone regeneration; The present arm received tooth extraction and guided bone regeneration (performed with xenograft porcine material and collagen barrier membrane). After 4 months, a dental implant was inserted.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Evaluation of new formed bone tissue	Evaluation of new formed bone tissue performed by histomorphometric methods.	Time of implant insertion: 4 months after extraction
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
Expression of Collagen A1	quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.	Time of implant insertion: 4 months after extraction
Expression of Osteocalcin	quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.	Time of implant insertion: 4 months after extraction
Expression of Osteopontin	quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.	Time of implant insertion: 4 months after extraction
Expression of Runx-2	quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.	Time of implant insertion: 4 months after extraction
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
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

Collaborators and Investigators

• Sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Investigators: Principal Investigator: Luigi Canullo, Studi Odontoiatrici Luigi Canullo

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Dental Implants, Alveolar Bone Loss, Alveolar Process
• Additional Relevant MeSH Terms: Nutrition Disorders; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Periodontal Atrophy; Vitamin D Deficiency; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: VITD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No