Clinical trial NCT04906161: Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
Official title: Correlation Between Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Dental Implant Failure Nos
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Systemic conditions
* Bad oral hygiene

Primary outcomes:
measure: Implant success with normal serum vitamin D level
timeFrame: 6 months
measure: Early implant failure with deficient serum vitamin D level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
city: Cairo
country: Egypt
facility: Doaa Khattab
state: Abbassia
Study officials:
affiliation: Ain Shams University
name: Bassem E Abd ElMoneim Hussein, MDs
role: PRINCIPAL_INVESTIGATOR
References: