Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration

NCT ID: NCT06776640

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2027-05-15

Brief Summary

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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

Detailed Description

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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. The investigator will present the study to them and record their verbal non-opposition. Clinical data from before the surgery (approximately 3 months prior), during the surgery, and postoperative visits up to 3 months afterward will be included in the OSIVID study.

Conditions

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Implant Site Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patient with supplementation of vitamin D3

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* with a local contraindication for implant placement.
* under guardianship, curatorship, or legal protection
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Gaelle Chaux, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Central Contacts

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Anne-Gaelle Chaux, MD PhD

Role: CONTACT

02 53 48 28 35

Alexandra Poinas, PhD

Role: CONTACT

0253482857

Other Identifiers

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AP_AGC_osivid_001

Identifier Type: -

Identifier Source: org_study_id

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