Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure

Vitamin D Deficiency Clinical Trial

Official title:

Correlation Between Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04906161
• Other study ID #: 1388
• Status: Recruiting
• Start date: January 20, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: Doaa Adel-Khattab, PhD
• Phone: +201006814258
• Email: dr.doaa.adel-khattab[@]dent.sasu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Missing single tooth

• Systemically free

• Average body mass index

Exclusion Criteria:

• Systemic conditions

• Bad oral hygiene

Related Conditions & MeSH terms

• Dental Implant Failure Nos
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• Vitamin D and calcium levels
Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abbassia
Egypt	Doaa Khattab	Cairo	Abbassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant success with normal serum vitamin D level	Implant stability with no further radiographic bone loss following bone remodeling with successful prosthetic part	6 months
Primary	Early implant failure with deficient serum vitamin D level	Mobile extruded implant with radiographic bone loss and peri-implant pathosis	6 months