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CompletedNCT06752642Updated Dec 31, 2024

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

An interventional study of Implant overdenture in Edentulism, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2022, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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
Read the 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

02

Conditions studied

  • Edentulism

Keywords

  • overdenture
  • implants
  • maxilla
  • edentulism
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    maxillary conventional denture and mandibular implant overdenture

    Participants have maxillary complete denture opposing mandibular implant overdenture

    Procedure: Implant overdenture

  • Active comparator
    maxillary and mandibular implant overdenture

    Participants have maxillary implant overdenture opposing mandibular implant overdenture

    Procedure: Implant overdenture

Interventions

  • ProcedureImplant overdenture

    patients received implant overdenture

06

What researchers measure

Primary outcomes

  1. bone height changes

    assessment of bone height changes in the premaxilla

    Time frame: 18 months

07

Study locations

1 site
  • Mansoura University
    Mansoura, Dakahlia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06752642
Lead sponsor
Mansoura University
Responsible party
Moataz Mohamed Soliman Elezaby (PhD researcher, Mansoura University) — Principal investigator
First posted
Dec 31, 2024
Start date
Jan 10, 2022
Primary completion
Sep 15, 2023
Completion
Oct 15, 2024
Last update
Dec 31, 2024

Study contacts

Moataz M. Elezaby, PhD student
principal investigator · Mansoura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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