Deficiency, Vitamin DPhase 1NCT03356730
Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants
A Phase 1 study testing Vitamin D in people with Deficiency, Vitamin D, run by Universidade de Passo Fundo at 1 site in Brazil.
Trial summary
1. Title 2. Executive team 3. Research line 4. Summary 5. Research problem 6. Justification 7. Literature review 8. Objectives 9. Materials and methods 10. Dissemination of knowledge generated 11. Schedule of activities 12. Budget 13. References 14. Annexes Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Deficiency, Vitamin D
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Nov 2017to 30 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both sexes;
- No medical, temporary or intra-oral contraindications;
- Good general health;
- Need of implant in the maxilla in the posterior region (with a minimum of 5 mm of bone height visualized radiographically) or in mandible in posterior region;
- With vitamin D deficiency / deficiency (considering serum level of ≥ 15 ng / ml at ≤ 25 ng / ml).
Who cannot join
- Medical, temporary or intrabuccal contraindications;
- Smokers;
- Use of corticoid;
- Post-operative of bariatric surgery;
- Bone height less than 5mm;
- Need for maxillary sinus lift;
- Vitamin supplementation D.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Isadora Rinaldi
Rondinha, Rio Grande do Sul, 99590-000
Isadora Rinaldi, Miss, 54996968365, 120910@upf.br
About this study
Official title: Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants: a Randomized Clinical Trial
- Title
- Executive team
- Research line
- Summary
- Research problem
- Justification
- Literature review
- Objectives
- Materials and methods
- Dissemination of knowledge generated
- Schedule of activities
- Budget
- References
- Annexes
Read the detailed description
This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. Background: Vitamin D replacement could aid in the osseointegration of dental implants. Objective: to evaluate the effect of vitamin D replacement on osseointegration of dental implants in humans. Materials and methods: Twenty individuals with hypovitaminosis D underwent dental miniimplants and randomized to two equal groups for treatment with vitamin D (5000 IU / day) or placebo for 2 months. After two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. Testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. Test t will be used to compare the differences between the groups.
- Conditions
- Deficiency, Vitamin D
- Being tested
- Vitamin D, Placebo
- Keywords
- Implants, Vitamin D, Osseointegration, Histomorphometric
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This group will receive vitamin D supplementation.
Vitamin D3 - cholecalciferol, oral suspension in drops, will be prescribed as follows:
- 5,000 IU / day - 10 drops per day for two months.
PlaceboOther
Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This control group will receive placebo.
Placebo (olive oil mint flavor), oral suspension in drops, will be prescribed as follows:
- 10 drops per day for two months.
| Study group | Role | What they receive |
|---|---|---|
| Arm vitamin D | Experimental | Vitamin D 5.000 IU a day for 2 months (10 drops after lunch) Receives: Drug: Vitamin D |
| Arm placebo | Placebo comparator | Placebo for 2 months (10 drops after lunch) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of bone implant contact
Histomorphometry will be used as a method of analysis. It will evaluate the initial stage of osseointegration in the two groups, relating it to insufficiency / deficiency and sufficiency of vitamin D. The percentage of bone implant contact, defined as the amount of mineralized bone in direct contact with the surface of the miniimplant, will be evaluated.
Measured: 2 months
Secondary outcomes (1)
Serum levels of vitamin D (ng/ml)
The 25-hydroxyvitamin D test is a common blood test and is the best way to monitor vitamin D levels. The test can determine if the person's blood has deficiency or excessive vitamin D. The method used to evaluate the blood test is chemiluminescent immunoassay technology (CLIA).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start19 Nov 2017
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency, Vitamin DStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isadora Rinaldi, Universidade de Passo Fundo
- Investigators
- Maria Salete Sandini Linden, Study director, Universidade de Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356730
- Sponsor's protocol ID
- UPassoFundo
- Status last verified
- Nov 2017
- First submitted
- 17 Aug 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participants data (IPD) will be available in the dental records including complementary exams, allowing the access of other researchers during the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03356730
- Acronym / sponsor ID
- UPassoFundo
- Conditions
- Deficiency, Vitamin D
- Keywords
- Implants, Vitamin D, Osseointegration, Histomorphometric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Study start
- 19 Nov 2017 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 29 Nov 2017 (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.
- Title
- Executive team
- Research line
- Summary
- Research problem
- Justification
- Literature review
- Objectives
- Materials and methods
- Dissemination of knowledge generated
- Schedule of activities
- Budget
- References
- Annexes
Detailed description
This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. Background: Vitamin D replacement could aid in the osseointegration of dental implants. Objective: to evaluate the effect of vitamin D replacement on osseointegration of dental implants in humans. Materials and methods: Twenty individuals with hypovitaminosis D underwent dental miniimplants and randomized to two equal groups for treatment with vitamin D (5000 IU / day) or placebo for 2 months. After two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. Testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. Test t will be used to compare the differences between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Arm vitamin D | Experimental | Drug: Vitamin DVitamin D 5.000 IU a day for 2 months (10 drops after lunch) |
| Arm placebo | Placebo comparator | Other: PlaceboPlacebo for 2 months (10 drops after lunch) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both sexes;
- No medical, temporary or intra-oral contraindications;
- Good general health;
- Need of implant in the maxilla in the posterior region (with a minimum of 5 mm of bone height visualized radiographically) or in mandible in posterior region;
- With vitamin D deficiency / deficiency (considering serum level of ≥ 15 ng / ml at ≤ 25 ng / ml).
Key exclusion criteria (7 listed)
- Medical, temporary or intrabuccal contraindications;
- Smokers;
- Use of corticoid;
- Post-operative of bariatric surgery;
- Bone height less than 5mm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DOnly patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This group will receive vitamin D supplementation. Vitamin D3 - cholecalciferol, oral suspension in drops, will be prescribed as follows: • 5,000 IU / day - 10 drops per day for two months. | Drug | Arm vitamin D |
| PlaceboOnly patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This control group will receive placebo. Placebo (olive oil mint flavor), oral suspension in drops, will be prescribed as follows: • 10 drops per day for two months. | Other | Arm placebo |
Primary outcome
Percentage of bone implant contact
Time frame: 2 months
Histomorphometry will be used as a method of analysis. It will evaluate the initial stage of osseointegration in the two groups, relating it to insufficiency / deficiency and sufficiency of vitamin D. The percentage of bone implant contact, defined as the amount of mineralized bone in direct contact with the surface of the miniimplant, will be evaluated.
1 secondary outcome
Serum levels of vitamin D (ng/ml)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Individual participant dataSharing planned: Yes. The individual participants data (IPD) will be available in the dental records including complementary exams, allowing the access of other researchers during the research.
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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. This study is not recruiting at the moment.
Maria Salete Sandini Linden study director
Universidade de Passo Fundo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Deficiency, Vitamin D, run by Universidade de Passo Fundo at 1 site in Brazil.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Nov 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isadora Rinaldi ((54) 9 9696-8365, 120910@upf.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of bone implant contact (time frame: 2 months). 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 29 Nov 2017.