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

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

Study Overview

• Status: Unknown
• Conditions: Deficiency, Vitamin D
• Intervention / Treatment: Drug: Vitamin D; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Isadora Rinaldi; Phone Number: (54) 9 9696-8365; Email: 120910@upf.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Rondinha, Rio Grande Do Sul, Brazil, 99590-000
      • Recruiting
      • Isadora Rinaldi
      • Contact: Isadora Rinaldi, Miss; Phone Number: 54996968365; Email: 120910@upf.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade de Passo Fundo
• Investigators: Study Director: Maria Salete Sandini Linden, Universidade de Passo Fundo

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2017
• Primary Completion (Anticipated): December 30, 2017
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; Osseointegration; Implants; Histomorphometric
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Avitaminosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: UPassoFundo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• 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