CD vs IOD Opposing Mandibular IOD : Bone Height Changes of the Premaxilla

Conventional Denture Versus Implant Overdenture Opposing Mandibular Implant Overdenture: Residual Alveolar Bone Height Changes of the Premaxilla

The goal of this clinical trial is to evaluate bone resorption of the anterior region of maxillary arch. The main questions it aims to answer are:

Does implants assisting maxillary complete denture enhance stability, retention and mastication of the patient ?

Does implants assisting maxillary complete denture reduce bone resorption in the anterior region of maxilla ?

Participants will:

• receive 2 implants with attachments assisting their maxillary complete denture
• Visit the clinic once every 6 months for checkups and tests

Study Overview

• Status: Completed
• Conditions: Edentulism
• Intervention / Treatment: Procedure: Implant overdenture

Detailed Description

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation.

The trial will include A total of twenty male adult patients unsatisfied with their maxillary complete denture seeking to enhance their mastication and esthetics. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.

each patient will receive 2 implants with attachments to assist their maxillary complete denture then follow up every 6 months for checkups.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. General good health without any systemic diseases affecting bone resorption such as uncontrolled diabetes or osteoporosis. This was confirmed through taking medical history and clinical examination by a physician.
2. Having angel's class I maxillo-mandibular relationships.
3. Presence of sufficient bone quality and quantity in the anterior region of maxilla and mandible which allow inserting implants of at least 3.75 mm diameter and 10 mm length. This was verified by Preoperative low dose Cone Beam (C.T) d) Presence of sufficient restorative space (a minimum of 15 mm must be available from the mucosa covering the crest of the residual ridge to the proposed occlusal plane), this was confirmed by tentative jaw relation.

(e) Having maladaptive maxillary conventional complete denture.

Exclusion Criteria:

1. Uncontrolled systemic diseases such as: uncontrolled hypertension, or uncontrolled cardiovascular disease
2. metabolic disorders such as diabetes mellitus
3. Patients with compromised immune systems as (Long term immunosuppressant and corticosteroid drug
4. TMJ dis orders and neuromuscular diseases
5. Patient with abnormal habits as clenching and bruxism, Smoking patient, Uncooperative patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: maxillary conventional denture and mandibular implant overdenture; Participants have maxillary complete denture opposing mandibular implant overdenture	Procedure: Implant overdenture; patients received implant overdenture
Active Comparator: maxillary and mandibular implant overdenture; Participants have maxillary implant overdenture opposing mandibular implant overdenture	Procedure: Implant overdenture; patients received implant overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone height changes	assessment of bone height changes in the premaxilla	18 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Moataz M. Elezaby, PhD student, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: edentulism; implants; overdenture; maxilla
• Other Study ID Numbers: M01030821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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