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

NCT ID: NCT06206005

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-04

Study Completion Date

2024-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Resorption

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group1 with Haemoglobin A1c ≤6.5%

This group represents a well-controlled type 2 Diabetics mellitus.

Observational study

Intervention Type OTHER

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.

Observational study

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational study

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Menoufia University

OTHER

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Elsawy

lecturer, Department of prosthodontics, principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mohammed ELSawy

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammed Elsawy, PhD

Role: CONTACT

00201061314522

Doaa A. mewafy, PhD

Role: CONTACT

00201061133971

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohammed Elsawy, PhD

Role: primary

00201061314522

Doaa A. Mewafy, PhD

Role: backup

00201061133971

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A03012023RP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3D-printed Implant Overdentures
NCT04569929 COMPLETED NA