Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration

NCT06776640 | Not Yet Recruiting

• 1 other identifier: AP_AGC_osivid_001
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The number of patients treated in Implantology at Nantes University Hospital is 400 per year. This pilot study aims to demonstrate the efficacy of a 6-month oral cholecalciferol supplementation on osseointegration in patients requiring dental implants and presenting with vitamin D deficiency, compared to French patients who have not undergone vitamin D screening

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

• The stability of the implan

  The stability of the implant measured by RFA (Resonance Frequency Analysis)

  3 months (surgery and 3 months after)

Study Arms (1)

patient with supplementation of vitamin D3

perioperative oral vitamin D3 supplementation on implant osseointegration in patients with vitamin D deficiency.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted on patients with vitamin D deficiency or insufficiency who visit the Restorative and Surgical Dentistry Department at the Dental Care Center of Nantes University Hospital for implant surgery.

You may qualify if:

• Male or female patient ≥ 18 years old, candidate for dental implant placement.
• with vitamin D deficiency or insufficiency: 25(OH)D \< 25 ng/L.
• affiliated with a social security scheme.

You may not qualify if:

• with a local contraindication for implant placement.
• under guardianship, curatorship, or legal protection
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Officials

• Anne-Gaelle Chaux, MD PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Gaelle Chaux, MD PhD

CONTACT

02 53 48 28 35; annegaelle.chaux@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

0253482857; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01