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Completed

NCT Number: NCT06412705

Vit D and Post-extractive Bone Turnover

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.

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Key information

Conditions

Vitamin D Deficiency Alveolar Bone Loss Alveolar Bone Resorption Avitaminosis Bone Diseases Bone Resorption Deficiency Diseases Malnutrition Mouth Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studi Odontoiatrici Luigi Canullo

Roma, RM, 00100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Dimensional alveolar bone changes

    Time frame: From extraction to implant insertion (4 months)

    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.

  2. Evaluation of new formed bone tissue

    Time frame: Time of implant insertion: 4 months after extraction

    Evaluation of new formed bone tissue performed by histomorphometric methods.

  3. Evaluation of Total Calcified Tissue (TCT)

    Time frame: Time of implant insertion: 4 months after extraction

    Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods.

  4. Expression of Collagen A1

    Time frame: Time of implant insertion: 4 months after extraction

    quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

  5. Expression of Osteocalcin

    Time frame: Time of implant insertion: 4 months after extraction

    quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

  6. Expression of Osteopontin

    Time frame: Time of implant insertion: 4 months after extraction

    quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

  7. Expression of Runx-2

    Time frame: Time of implant insertion: 4 months after extraction

    quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.

  8. Evaluation of Implant Stability Quotient (ISQ)

    Time frame: Time of implant insertion: 4 months after extraction

    Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W&H)

  9. Evaluation of Implant Torque Value (ITV)

    Time frame: Time of implant insertion: 4 months after extraction

    Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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