Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes

Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206005
• Other study ID #: A03012023RP
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Bone Resorption

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