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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Dental Implant Failure Nos
• Intervention / Treatment: Diagnostic test: Vitamin D and calcium levels

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: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Doaa Adel-Khattab, PhD; Phone Number: +201006814258; Email: dr.doaa.adel-khattab@dent.sasu.edu.eg

Study Locations

• Egypt
  • 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: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multicenter study on systemically free participants that had a dental implant within the last 6 months using the same implant system, preoperative planning techniques, surgical protocol (minimal invasive implant concept), post surgical protocol and excluding any cases with intrasurgical difficulties and complications.

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Successful dental implant; Patients showed a successful implant placement with no complications before loading	Diagnostic test: Vitamin D and calcium levels; Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)
Early dental implant failure; Early complications and failure of dental implant before loading	Diagnostic test: Vitamin D and calcium levels; 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	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	Mobile extruded implant with radiographic bone loss and peri-implant pathosis	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Bassem E Abd ElMoneim Hussein, MDs, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Anticipated): July 20, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: 1388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No