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

NCT ID: NCT03356730

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-19

Study Completion Date

2018-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Deficiency, Vitamin D

Keywords

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Implants Vitamin D Osseointegration Histomorphometric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Masking for placebo or vitamin D use

Study Groups

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Arm vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type 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 placebo

Placebo for 2 months (10 drops after lunch)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade de Passo Fundo

OTHER

Sponsor Role lead

Responsible Party

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Isadora Rinaldi

Master Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Salete Sandini Linden

Role: STUDY_DIRECTOR

Universidade de Passo Fundo

Locations

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Isadora Rinaldi

Rondinha, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Isadora Rinaldi

Role: CONTACT

Phone: (54) 9 9696-8365

Email: [email protected]

Facility Contacts

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Isadora Rinaldi, Miss

Role: primary

Other Identifiers

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UPassoFundo

Identifier Type: -

Identifier Source: org_study_id