Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants
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|ClinicalTrials.gov Identifier: NCT03356730|
Recruitment Status : Unknown
Verified November 2017 by Isadora Rinaldi, Universidade de Passo Fundo.
Recruitment status was: Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
- Executive team
- Research line
- Research problem
- Literature review
- Materials and methods
- Dissemination of knowledge generated
- Schedule of activities
|Condition or disease||Intervention/treatment||Phase|
|Deficiency, Vitamin D||Drug: Vitamin D Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled trial.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Masking for placebo or vitamin D use|
|Official Title:||Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants: a Randomized Clinical Trial|
|Actual Study Start Date :||November 19, 2017|
|Estimated Primary Completion Date :||December 30, 2017|
|Estimated Study Completion Date :||April 30, 2018|
Experimental: Arm vitamin D
Vitamin D 5.000 IU a day for 2 months (10 drops after lunch)
Drug: Vitamin D
Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This group will receive vitamin D supplementation.
Vitamin D3 - cholecalciferol, oral suspension in drops, will be prescribed as follows:
• 5,000 IU / day - 10 drops per day for two months.
Placebo Comparator: Arm placebo
Placebo for 2 months (10 drops after lunch)
Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This control group will receive placebo.
Placebo (olive oil mint flavor), oral suspension in drops, will be prescribed as follows:
• 10 drops per day for two months.
- Percentage of bone implant contact [ Time Frame: 2 months ]Histomorphometry will be used as a method of analysis. It will evaluate the initial stage of osseointegration in the two groups, relating it to insufficiency / deficiency and sufficiency of vitamin D. The percentage of bone implant contact, defined as the amount of mineralized bone in direct contact with the surface of the miniimplant, will be evaluated.
- Serum levels of vitamin D (ng/ml) [ Time Frame: 2 months ]The 25-hydroxyvitamin D test is a common blood test and is the best way to monitor vitamin D levels. The test can determine if the person's blood has deficiency or excessive vitamin D. The method used to evaluate the blood test is chemiluminescent immunoassay technology (CLIA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356730
|Contact: Isadora Rinaldi||(54) 9 email@example.com|
|Rondinha, Rio Grande Do Sul, Brazil, 99590-000|
|Contact: Isadora Rinaldi, Miss 54996968365 firstname.lastname@example.org|
|Study Director:||Maria Salete Sandini Linden||Universidade de Passo Fundo|