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

Recruiting

• Conditions: Bone Resorption
• Interventions: Other: Observational study

• Registration Number: NCT06206005
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2023-12-04
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-05-05
• Study Completion: 2024-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1 with Haemoglobin A1c ≤6.5%	Observational study	This group represents a well-controlled type 2 Diabetics mellitus.
Group 2 with Haemoglobin A1c >6.5%	Observational study	This group represents a poorly controlled type 2 Diabetics mellitus.

Primary Outcome Measures

Name	Time	Method
Crestal bone loss around implants	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 Outcome Measures

Name	Time	Method
Probing depth	This is a retrospective study, Measurement will be performed after implants being in service by 10 years	By using a plastic periodontal probe to measure the probing depth around the implants

Trial Locations

Locations (1)

Mohammed ELSawy; 🇪🇬 Mansoura, Egypt