- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906161
Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
Correlation Between Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osseointegration is a complex phenomenon and depends on many factors; some are related to the implant (material, macroscopic design, and implant surface), others to the surgical-prosthetic protocol (surgical technique, loading conditions, and time), and others to the patient (quantity/quality of bone at the receiving site and the host response)
All these observations would suggest the existence of specific patient-related risk factors such as vitamin D deficiency in the blood, could play an important role in the occurrence of early dental implant failures (EDIFs), but unfortunately are neglected by the dental literature.
In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D. Therefore we are including patients with early implant failure during the year 2020 using the same implant (material, macroscopic design, and implant surface), surgical-prosthetic protocol (surgical technique, loading conditions, and time)
The study will be performed into 15 male and 15 female participants that had dental implant placement in the last 3 months. An informed consent will be signed with the patient with full detail on the study.
The situation of the implant will be categorized into either successful or failed dental implant.
Medical history and lifestyle information will be obtained by questionnaire. Levels of serum vitamin D will be collected from participants
Statistical analysis will correlate between vitamin D and early implant failure.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Doaa Adel-Khattab, PhD
- Phone Number: +201006814258
- Email: dr.doaa.adel-khattab@dent.sasu.edu.eg
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 11566
- Recruiting
- Ain Shams University
-
Contact:
- Doaa Adel-Khattab, PhD
- Phone Number: +201006814258
- Email: dr.doaa.adel-khattab@dent.asu.edu.eg
-
Contact:
- Mohamed S El-Mofty, PhD
- Phone Number: +201001431000
- Email: mofty@dr.com
-
Cairo, Abbassia, Egypt, 11566
- Recruiting
- Doaa Khattab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Missing single tooth
- Systemically free
- Average body mass index
Exclusion Criteria:
- Systemic conditions
- Bad oral hygiene
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Successful dental implant
Patients showed a successful implant placement with no complications before loading
|
Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)
|
Early dental implant failure
Early complications and failure of dental implant before loading
|
Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant success with normal serum vitamin D level
Time Frame: 6 months
|
Implant stability with no further radiographic bone loss following bone remodeling with successful prosthetic part
|
6 months
|
Early implant failure with deficient serum vitamin D level
Time Frame: 6 months
|
Mobile extruded implant with radiographic bone loss and peri-implant pathosis
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bassem E Abd ElMoneim Hussein, MDs, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1388
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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