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

Deficiency, Vitamin D Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356730
• Other study ID #: UPassoFundo
• Status: Recruiting
• Phase: Phase 1
• First received: August 17, 2017
• Last updated: November 28, 2017
• Start date: November 19, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: November 2017
• Source: Universidade de Passo Fundo
• Contact: Isadora Rinaldi
• Phone: (54) 9 9696-8365
• Email: 120910[@]upf.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avitaminosis
• Deficiency, Vitamin D
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
Brazil	Isadora Rinaldi	Rondinha	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade de Passo Fundo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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