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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06206005
Other study ID # A03012023RP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 4, 2023
Est. completion date August 5, 2024

Study information

Verified date January 2024
Source Mansoura University
Contact Mohammed Elsawy, PhD
Phone 00201061314522
Email Dr_sawy@windowslive.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.


Description:

Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients. Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 5, 2024
Est. primary completion date May 5, 2024
Accepts healthy volunteers
Gender All
Age group 55 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with edentulous maxilla and mandible for at least 12 months. - Patients have problems with mandibular denture retention and stability. - Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region. Exclusion Criteria: - Patients who did not receive implants at the department clinic. - Patients with more or less than 4 implants in the mandible. - Patients with well controlled diabetics. - Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism. - Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational study
evaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function.

Locations

Country Name City State
Egypt Mohammed ELSawy Mansoura

Sponsors (2)

Lead Sponsor Collaborator
Mansoura University Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Crestal bone loss around implants amount of bone loss which appears on a periapical radiograph This is a retrospective study, Measurement will be performed after implants being in service by 10 years
Secondary Probing depth By using a plastic periodontal probe to measure the probing depth around the implants This is a retrospective study, Measurement will be performed after implants being in service by 10 years
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