NCT03356730

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Universidade de Passo Fundo · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Deficiency, Vitamin D

Interventions

Type	Name	Description
DRUG	Vitamin 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.
OTHER	Placebo	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.

Timeline

• Start date: 2017-11-19
• Primary completion: 2017-12-30
• Completion: 2018-04-30
• First posted: 2017-11-29
• Last updated: 2017-11-29

Locations

1 site across 1 country: Brazil