Systemic Vitamin D Supplementation in Dental Implants Patients

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Vit D

• Registration Number: NCT02582892
• Lead Sponsor: University Potiguar

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-10
• Status Verified: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vit D	Vit D	Vit D 20 mg/day

Primary Outcome Measures

Name	Time	Method
25 OH Serum levels	2 years	VIT D Serum levels

Secondary Outcome Measures

Name	Time	Method
Osteoporosis condition	2 years	Densitometry in patients femur bones

Trial Locations

Locations (3)

University Potiguar; 🇧🇷 Natal, RN, Brazil

Gynelogical Center; 🇧🇷 Fortaleza, CE, Brazil

Marco Botelho; 🇧🇷 Sao Paulo, Brazil