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

NCT03356730 | Unknown Phase 1 DMC

• 1 other identifier: UPassoFundo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Title
2. 2.Executive team
3. 3.Research line
4. 4.Summary
5. 5.Research problem
6. 6.Justification
7. 7.Literature review
8. 8.Objectives
9. 9.Materials and methods
10. 10.Dissemination of knowledge generated
11. 11.Schedule of activities
12. 12.Budget
13. 13.References
14. 14.Annexes

Conditions

Deficiency, Vitamin D

Keywords

Implants; Vitamin D; Osseointegration; Histomorphometric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serum levels of vitamin D (ng/ml)

  2 months

Study Arms (2)

Arm vitamin D

EXPERIMENTAL

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

Drug: Vitamin D

Arm placebo

PLACEBO COMPARATOR

Placebo for 2 months (10 drops after lunch)

Other: Placebo

Interventions

Vitamin D DRUG

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.

Arm vitamin D

Placebo OTHER

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.

Arm placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade de Passo Fundo: lead

Study Sites (1)

Isadora Rinaldi

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

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Maria Salete Sandini Linden

  Universidade de Passo Fundo

  STUDY DIRECTOR

Central Study Contacts

Isadora Rinaldi

CONTACT

(54) 9 9696-8365; 120910@upf.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking for placebo or vitamin D use
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Model Details: This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: November 29, 2017
• Study Start: November 19, 2017
• Primary Completion: December 30, 2017
• Study Completion: April 30, 2018
• Last Updated: November 29, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)