Deficiency, Vitamin D
Conditions
Keywords
Implants, Vitamin D, Osseointegration, Histomorphometric
Brief 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
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.
Interventions
DRUGVitamin D
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.
OTHERPlacebo
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.
Sponsors
Universidade de Passo Fundo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Masking for placebo or vitamin D use
Intervention model description
This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of bone implant contact | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of vitamin D (ng/ml) | 2 months | 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). |
Countries
Brazil
Contacts
Primary ContactIsadora Rinaldi
Outcome results
None listed