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Clinical Trials/NCT06752642
NCT06752642
Completed
N/A

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

Mansoura University1 site in 1 country20 target enrollmentJanuary 10, 2022
ConditionsEdentulism

Overview

Phase
N/A
Intervention
Not specified
Conditions
Edentulism
Sponsor
Mansoura University
Enrollment
20
Locations
1
Primary Endpoint
bone height changes
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
October 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moataz Mohamed Soliman Elezaby

PhD researcher

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Having angel's class I maxillo-mandibular relationships.
  • 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

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

Outcomes

Primary Outcomes

bone height changes

Time Frame: 18 months

assessment of bone height changes in the premaxilla

Study Sites (1)

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