NCT04906161

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 6, 2021

Last Update Submit

May 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Successful dental implant

Patients showed a successful implant placement with no complications before loading

Diagnostic Test: Vitamin D and calcium levels

Early dental implant failure

Early complications and failure of dental implant before loading

Diagnostic Test: Vitamin D and calcium levels

Interventions

Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)

Early dental implant failureSuccessful dental implant

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Missing single tooth
  • Systemically free
  • Average body mass index

You may not qualify if:

  • Systemic conditions
  • Bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

RECRUITING

Doaa Khattab

Cairo, Abbassia, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Bassem E Abd ElMoneim Hussein, MDs

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 28, 2021

Study Start

January 20, 2021

Primary Completion

July 20, 2021

Study Completion

June 30, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations