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

Phase 1

• Conditions: Deficiency, Vitamin D
• Interventions: Drug: Vitamin D; Other: Placebo

• Registration Number: NCT03356730
• Lead Sponsor: Universidade de Passo Fundo

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.

Study Timeline

• Study First Submitted: 2017-08-17
• Status Verified: 2017-11
• Study Start: 2017-11-19
• Study First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-28
• Study First Posted: 2017-11-29
• Last Update Posted: 2017-11-29
• Primary Completion: 2017-12-30
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm vitamin D	Vitamin D	Vitamin D 5.000 IU a day for 2 months (10 drops after lunch)
Arm placebo	Placebo	Placebo for 2 months (10 drops after lunch)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Isadora Rinaldi; 🇧🇷 Rondinha, Rio Grande Do Sul, Brazil