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

• ClinicalTrials.gov Identifier: NCT03356730
• Recruitment Status: Unknown
• First Posted: November 29, 2017
• Last Update Posted: November 29, 2017
• Sponsor: Universidade de Passo Fundo
• Information provided by (Responsible Party): Isadora Rinaldi, Universidade de Passo Fundo

Study Description

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

Condition or disease	Intervention/treatment	Phase
Deficiency, Vitamin D	Drug: Vitamin D; Other: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
• Masking: Double (Participant, Investigator)
• Masking Description: Masking for placebo or vitamin D use
• Primary Purpose: Treatment
• Official Title: Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants: a Randomized Clinical Trial
• Actual Study Start Date: November 19, 2017
• Estimated Primary Completion Date: December 30, 2017
• Estimated Study Completion Date: April 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm vitamin D; Vitamin D 5.000 IU a day for 2 months (10 drops after lunch)	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.
Placebo Comparator: Arm placebo; Placebo for 2 months (10 drops after lunch)	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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of bone implant contact [ Time Frame: 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 :

1. Serum levels of vitamin D (ng/ml) [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Isadora Rinaldi; (54) 9 9696-8365; 120910@upf.br

Locations

Brazil

Isadora Rinaldi; Recruiting

Rondinha, Rio Grande Do Sul, Brazil, 99590-000

Contact: Isadora Rinaldi, Miss 54996968365 120910@upf.br

Sponsors and Collaborators

Universidade de Passo Fundo

Investigators

• Study Director: Maria Salete Sandini Linden; Universidade de Passo Fundo

More Information

• Responsible Party: Isadora Rinaldi, Master Student, Universidade de Passo Fundo
• ClinicalTrials.gov Identifier: NCT03356730
• Other Study ID Numbers: UPassoFundo
• First Posted: November 29, 2017
• Last Update Posted: November 29, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The individual participants data (IPD) will be available in the dental records including complementary exams, allowing the access of other researchers during the research.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Isadora Rinaldi, Universidade de Passo Fundo:

Implants; Vitamin D; Osseointegration; Histomorphometric

Additional relevant MeSH terms:

Avitaminosis; Vitamin D Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents