Implant Site ReactionOSIVIDNCT06776640
Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration
An observational study of Implant Site Reaction, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant Site Reaction
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2025to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- with a local contraindication for implant placement.
- under guardianship, curatorship, or legal protection
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes-Department of Dentistry
Nantes, Nantes, 44000
Alexandra Poinas, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
Official title: Efficacy of Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration in Patients With Vitamin D Deficiency
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
Read the detailed description
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
- Implant Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with supplementation of vitamin D3 | perioperative oral vitamin D3 supplementation on implant osseointegration in patients with vitamin D deficiency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The stability of the implan
The stability of the implant measured by RFA (Resonance Frequency Analysis)
Measured: 3 months (surgery and 3 months after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Gaelle Chaux, MD PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776640
- Sponsor's protocol ID
- AP_AGC_osivid_001
- Acronym
- OSIVID
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration in Patients With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT06776640
- Acronym / sponsor ID
- OSIVID / AP_AGC_osivid_001
- Conditions
- Implant Site Reaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with supplementation of vitamin D3 | – | –perioperative oral vitamin D3 supplementation on implant osseointegration in patients with vitamin D deficiency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- with a local contraindication for implant placement.
- under guardianship, curatorship, or legal protection
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The stability of the implan
Time frame: 3 months (surgery and 3 months after)
The stability of the implant measured by RFA (Resonance Frequency Analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Gaelle Chaux, MD PhD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Site Reaction, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Gaelle Chaux, MD PhD (02 53 48 28 35, annegaelle.chaux@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The stability of the implan (time frame: 3 months (surgery and 3 months after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.