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

Universidade de Passo Fundo

Status and phase: Unknown; Phase 1

Conditions: Deficiency, Vitamin D

Treatments: Drug: Vitamin D; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03356730

UPassoFundo

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Arm vitamin D

Experimental group

Description:

Vitamin D 5.000 IU a day for 2 months (10 drops after lunch)

Treatment:

Drug: Vitamin D

Arm placebo

Placebo Comparator group

Description:

Placebo for 2 months (10 drops after lunch)

Treatment:

Other: Placebo