Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants: a Randomized Clinical Trial

Conditions
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Deficiency, Vitamin D

Intervention / Treatment
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* Drug: Vitamin D
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm vitamin D<br>Vitamin D 5.000 IU a day for 2 months (10 drops after lunch) | Drug: Vitamin D<br>* 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.<br>|
| Placebo Comparator: Arm placebo<br>Placebo for 2 months (10 drops after lunch) | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implants, Vitamin D, Osseointegration, Histomorphometric