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OpenTrials
Completed

NCT Number: NCT02582892

Systemic Vitamin D Supplementation in Dental Implants Patients

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

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Key information

Age range

3 month–5 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Gynelogical Center, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vit D

Drug

20 mg/day

Other names: Vitamin D

Primary outcomes

  1. 25 OH Serum levels

    Time frame: 2 years

    VIT D Serum levels

Secondary outcomes

  1. Osteoporosis condition

    Time frame: 2 years

    Densitometry in patients femur bones

Sponsors and collaborators

Lead sponsor

University Potiguar

Other

Registry information

Official study title

Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants

Acronym: VitaminD

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Oct 21, 2015
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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