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Clinical Trials/NCT06206005
NCT06206005
Recruiting
Not Applicable

Clinical and Radiographic Outcomes Around Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes: A Long-term Retrospective Preliminary Study

Mansoura University1 site in 1 country20 target enrollmentDecember 4, 2023
ConditionsBone Resorption

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Resorption
Sponsor
Mansoura University
Enrollment
20
Locations
1
Primary Endpoint
Crestal bone loss around implants
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
December 4, 2023
End Date
August 5, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Elsawy

lecturer, Department of prosthodontics, principle investigator

Mansoura University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Crestal bone loss around implants

Time Frame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years

amount of bone loss which appears on a periapical radiograph

Secondary Outcomes

  • Probing depth(This is a retrospective study, Measurement will be performed after implants being in service by 10 years)

Study Sites (1)

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