Systemic Vitamin D Supplementation in Dental Implants Patients

Osteoporosis Clinical Trial

— VitaminD  

Official title:

Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582892
• Other study ID #: EVIDENCE x UNP VITAMIN D
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2015
• Last updated: October 21, 2015
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University Potiguar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 3 Months to 5 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Vit D
20 mg/day

Locations

Country	Name	City	State
Brazil	Gynelogical Center	Fortaleza	CE
Brazil	University Potiguar	Natal	RN
Brazil	Marco Botelho	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University Potiguar

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25 OH Serum levels	VIT D Serum levels	2 years	No
Secondary	Osteoporosis condition	Densitometry in patients femur bones	2 years	No