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

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

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

Study Overview

• Status: Recruiting
• Conditions: Bone Resorption
• Intervention / Treatment: Other: Observational study

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Mohammed Elsawy, PhD; Phone Number: 00201061314522; Email: Dr_sawy@windowslive.com
• Study Contact Backup: Name: Doaa A. Mewafy, PhD; Phone Number: 00201061133971; Email: Doaamowafy@mans.edu.eg

Study Locations

• Egypt
  • Mansoura, Egypt, 12345
    • Recruiting
    • Mohammed ELSawy
    • Contact: Mohammed Elsawy, PhD; Phone Number: 00201061314522; Email: Dr_sawy@windowslive.com
    • Contact: Doaa A. Mewafy, PhD; Phone Number: 00201061133971; Email: Doaamowafy@mans.edu.eg
    • Sub-Investigator: Sherine Donia, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

20 participants at least.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1 with Haemoglobin A1c ≤6.5%; This group represents a well-controlled type 2 Diabetics mellitus.	Other: Observational study; evaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function.
Group 2 with Haemoglobin A1c >6.5%; This group represents a poorly controlled type 2 Diabetics mellitus.	Other: Observational study; evaluate implant survival, peri-implant outcome of 4 implant retained mandibular OVD after 10 years of function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): May 5, 2024
• Study Completion (Estimated): August 5, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: A03012023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD is upon request from the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No