Vit D and Post-extractive Bone Turnover

NCT ID: NCT06412705

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-04-30

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).

Conditions

Vitamin D Deficiency; Alveolar Bone Loss; Alveolar Bone Resorption

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tooth extraction, guided bone regeneration and dental implant

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Canullo

Role: PRINCIPAL_INVESTIGATOR

Studi Odontoiatrici Luigi Canullo

Locations

Studi Odontoiatrici Luigi Canullo

Roma, RM, Italy

Countries

Italy

Other Identifiers

VITD-01

Identifier Type: -

Identifier Source: org_study_id