Correlation Between Vitamin D Serum Level and Early Implant Failure

NCT05956561 | Completed DMC

• 1 other identifier: EDIF 863
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate relation between serum vitamin D levels and early implant failure. in all patient seeking delayed dental implant placement at Faculty of Dentistry, Ain Shams University from September 2020 to April 2023, all the patients must fulfil the inclusion criteria including age above 18, no medical condition interference and compliance to study. The main question\[s\] it aims to answer are:

• is vitamin D deficiency caustic to early implant failure
• can implant stability indicate implant failure Participants will receive implants and prosthetic rehabilitated according to each case.

Conditions

Endosseous Dental Implant Failure

Keywords

early implant failure; implant stability; vitamin D

Outcome Measures

Primary Outcomes (1)

• early implant failure relation to vitamin D serum level

  evaluation early implant failure within 3 months of implant placement using clinical and radiographic methods. implant consider failed if failed to osseointegrate without infection signs or failed with infection present showing signs of infection as pain, mobility, swelling and marginal bone loss more than 2.5 mm after 12 weeks of implant placement. Side by side with measuring implant stability at implant placement time and 12 weeks Laters. data were correlated with vitamin D serum levels.

  12 weeks

Study Arms (1)

only one group

all patients seeking delayed dental implant placement above 18 years and medical free, no previous augmentation or sinus lifting

Other: dental implants were placed for all cases while assessing vitamin D levels

Interventions

dental implants were placed for all cases while assessing vitamin D levels OTHER

vitamin D assessment with measuring implant stability and clinical finding of early failure

only one group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The present study will be selected from those seeking delayed dental implant selected from those attending the outpatient clinic at Oral and Maxillofacial Surgery Department in the Faculty of Dentistry, Ain Shams University from February 2020 to February 2021. The following data will be collected from each patient through diagnostic chart as follow: Personal data, chief complaint, full medical history, dental history, family history and personal habits as smoking, alcohol consumption and habits related to the oral hygiene. The study protocol will be explained to all prospective candidates, and a written informed consent will be received from each patient before participation. All the data will be reviewed by ethics commits of faculty of dentistry Ain Shams University.

You may qualify if:

• \. Patients with vitamin D sufficient, insufficient, and deficient according to Enzyme Immunoassay test. 2. Patients with horizontal ridge width and vertical ridge height, according to class III of Cawood and Howell classification. 3. Patients with matched parameters of implant including diameter, length and manufacturing. 4. Patients' compliance to oral hygiene measures. 5. Compliance with all requirements in the study and signing the informed consent. 6. Patient with sufficient inter arch space.

You may not qualify if:

• \. Patients with diseases of the immune system or any medical condition that may influence the outcome. 2. Patients with history of intravenous and/or oral bisphosphonate use. 3. Pathologic lesions in the site of implant placement. 4. Patients who are pregnant or lactating mothers. 5. Smokers patients. 6. Patients with poor oral hygiene habits that are not amenable to motivation and improvement. 7. Patients with history of irradiation of the head and neck region. 8. Patients who need pre-surgical augmentation for the alveolar ridge or sinus lift. 9. Patients need immediate implant placement.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry Ain Shams University

Cairo, 11566, Egypt

Location

Study Officials

• Mona Abd El-Raouf, BDS

  Ain Shams University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mona Nady Abd El-Raouf

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: September 20, 2020
• Primary Completion: April 29, 2023
• Study Completion: April 29, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

EG (1)