Systemic Vitamin D Supplementation in Dental Implants Patients

Overview

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

Full Title of Study: “Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2013

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.

Interventions

  • Drug: Vit D
    • 20 mg/day

Arms, Groups and Cohorts

  • Other: Vit D
    • Vit D 20 mg/day

Clinical Trial Outcome Measures

Primary Measures

  • 25 OH Serum levels
    • Time Frame: 2 years
    • VIT D Serum levels

Secondary Measures

  • Osteoporosis condition
    • Time Frame: 2 years
    • Densitometry in patients femur bones

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 3 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Potiguar
  • Provider of Information About this Clinical Study
    • Principal Investigator: MARCO BOTELHO, Program Director of Graduate Biotechnology – University Potiguar
  • Overall Official(s)
    • Gugliemo G Campus, PhD, Study Chair, Università degli Studi di Sassari

Citations Reporting on Results

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.