Clinical trial NCT02582892: Systemic Vitamin D Supplementation in Dental Implants Patients
Official title: Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: University Potiguar
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 135
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 25 OH Serum levels
timeFrame: 2 years
Secondary outcomes:
measure: Osteoporosis condition
timeFrame: 2 years
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Gynelogical Center
state: CE
city: Natal
country: Brazil
facility: University Potiguar
state: RN
city: Sao Paulo
country: Brazil
facility: Marco Botelho
Study officials:
affiliation: Università degli Studi di Sassari
name: Gugliemo G Campus, PhD
role: STUDY_CHAIR
References:
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 spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
citation: 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.