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

Universidade de Passo Fundo20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Deficiency, Vitamin D

Interventions

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Isadora Rinaldi

Rondinha, Rio Grande do Sul, Brazil

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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).

Time frame: 2 months

Central Contacts

Isadora Rinaldi

CONTACT

(54) 9 9696-8365 120910@upf.br

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.