Systemic Vitamin D Supplementation in Dental Implants Patients

NCT ID: NCT02582892

Last Updated: 2015-10-22

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-10-31

Brief Summary

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Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.

Detailed Description

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Evidence has demonstrated that vitamin D deficiency plays an important role in dental implants outcomes.

Low serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases.

There are few studies demonstrating the role that vitamin D deficiency in the etiopathogenesis of oral diseases and the consequences in Dental Implants.

Dentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants.

An insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology.

Thus, the aim of this study is to evaluate the efficacy of Systemic vitamin D supplementation in menopausal women cadidates for dental implants.

Conditions

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vit D

Vit D 20 mg/day

Group Type OTHER

Vit D

Intervention Type DRUG

20 mg/day

Interventions

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Vit D

20 mg/day

Intervention Type DRUG

Other Intervention Names

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Vitamin D

Eligibility Criteria

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Inclusion Criteria

\- Menopause patients

Exclusion Criteria

* patients with a past history of neurological disorder;
* who had received pharmacotherapy for depression within 8 weeks of screening;
* who were taking medication known to interfere with Vit D;
* who had recent psychiatricor systemic illness;
* uncontrolled hypertension (blood pressure \> 160/95mmHg);
* unstable cardiovascular disease;
* User of psychoactive medications;
* alcohol excess consumption abuse.
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Potiguar

OTHER

Sponsor Role lead

Responsible Party

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MARCO BOTELHO

Program Director of Graduate Biotechnology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gugliemo G Campus, PhD

Role: STUDY_CHAIR

Università degli Studi di Sassari

Locations

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Gynelogical Center

Fortaleza, Ceará, Brazil

Site Status

University Potiguar

Natal, Rio Grande do Norte, Brazil

Site Status

Marco Botelho

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.

Reference Type RESULT
PMID: 24519196 (View on PubMed)

Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.

Reference Type RESULT
PMID: 20835566 (View on PubMed)

Other Identifiers

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EVIDENCE x UNP VITAMIN D

Identifier Type: -

Identifier Source: org_study_id

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