Vit D and Post-extractive Bone Turnover

NCT06412705 | Completed

• 1 other identifier: VITD-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Alveolar Bone Loss; Alveolar Bone Resorption

Keywords

Dental Implants, Alveolar Bone Loss, Alveolar Process

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Tooth extraction and bone regeneration

EXPERIMENTAL

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

Interventions

Tooth extraction, guided bone regeneration and dental implant PROCEDURE

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

Tooth extraction and bone regeneration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult (≥ 18 years old)
• Patients willing to participate and to attend the planned follow-up visits

You may not qualify if:

• 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

Sponsors & Collaborators

• Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo: lead

Study Sites (1)

Studi Odontoiatrici Luigi Canullo

Roma, RM, 00100, Italy

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Alveolar Bone Loss

Interventions

Tooth Extraction; Dental Implants

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Luigi Canullo

  Studi Odontoiatrici Luigi Canullo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 14, 2024
• Study Start: October 2, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)