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

NCT ID: NCT04906161

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-20

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitamin D Deficiency Dental Implant Failure Nos

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Successful dental implant

Patients showed a successful implant placement with no complications before loading

Vitamin D and calcium levels

Intervention Type DIAGNOSTIC_TEST

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

Early dental implant failure

Early complications and failure of dental implant before loading

Vitamin D and calcium levels

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Vitamin D and calcium levels

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Systemic conditions
* Bad oral hygiene
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Adel Salah Khattab

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bassem E Abd ElMoneim Hussein, MDs

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, Abbassia, Egypt

Site Status RECRUITING

Doaa Khattab

Cairo, Abbassia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Doaa Adel-Khattab, PhD

Role: CONTACT

Phone: +201006814258

Email: [email protected]

Facility Contacts

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Doaa Adel-Khattab, PhD

Role: primary

Mohamed S El-Mofty, PhD

Role: backup

Other Identifiers

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1388

Identifier Type: -

Identifier Source: org_study_id