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Effect of Vitamin D Replacement on Bone Healing in Mini-dental Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Isadora Rinaldi, Universidade de Passo Fundo

Brief Summary:
  1. Title
  2. Executive team
  3. Research line
  4. Summary
  5. Research problem
  6. Justification
  7. Literature review
  8. Objectives
  9. Materials and methods
  10. Dissemination of knowledge generated
  11. Schedule of activities
  12. Budget
  13. References
  14. Annexes

Condition or disease Intervention/treatment Phase
Deficiency, Vitamin D Drug: Vitamin D Other: Placebo Phase 1

Detailed Description:
This is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. Background: Vitamin D replacement could aid in the osseointegration of dental implants. Objective: to evaluate the effect of vitamin D replacement on osseointegration of dental implants in humans. Materials and methods: Twenty individuals with hypovitaminosis D underwent dental miniimplants and randomized to two equal groups for treatment with vitamin D (5000 IU / day) or placebo for 2 months. After two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. Testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. Test t will be used to compare the differences between the groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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)
Other: Placebo

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of both sexes;
  • No medical, temporary or intra-oral contraindications;
  • Good general health;
  • Need of implant in the maxilla in the posterior region (with a minimum of 5 mm of bone height visualized radiographically) or in mandible in posterior region;
  • With vitamin D deficiency / deficiency (considering serum level of ≥ 15 ng / ml at ≤ 25 ng / ml).

Exclusion Criteria:

  • Medical, temporary or intrabuccal contraindications;
  • Smokers;
  • Use of corticoid;
  • Post-operative of bariatric surgery;
  • Bone height less than 5mm;
  • Need for maxillary sinus lift;
  • Vitamin supplementation D.

Information from the National Library of Medicine

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


Contacts
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Contact: Isadora Rinaldi (54) 9 9696-8365 120910@upf.br

Locations
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Brazil
Isadora Rinaldi Recruiting
Rondinha, Rio Grande Do Sul, Brazil, 99590-000
Contact: Isadora Rinaldi, Miss    54996968365    120910@upf.br   
Sponsors and Collaborators
Universidade de Passo Fundo
Investigators
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Study Director: Maria Salete Sandini Linden Universidade de Passo Fundo
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Responsible Party: Isadora Rinaldi, Master Student, Universidade de Passo Fundo
ClinicalTrials.gov Identifier: NCT03356730    
Other Study ID Numbers: UPassoFundo
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The individual participants data (IPD) will be available in the dental records including complementary exams, allowing the access of other researchers during the research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Isadora Rinaldi, Universidade de Passo Fundo:
Implants
Vitamin D
Osseointegration
Histomorphometric
Additional relevant MeSH terms:
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Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents