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

NCT06752642 | Completed

• 1 other identifier: M01030821
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Edentulism

Keywords

overdenture; implants; maxilla; edentulism

Outcome Measures

Primary Outcomes (1)

• bone height changes

  assessment of bone height changes in the premaxilla

  18 months

Study Arms (2)

maxillary conventional denture and mandibular implant overdenture

ACTIVE COMPARATOR

Participants have maxillary complete denture opposing mandibular implant overdenture

Procedure: Implant overdenture

maxillary and mandibular implant overdenture

ACTIVE COMPARATOR

Participants have maxillary implant overdenture opposing mandibular implant overdenture

Procedure: Implant overdenture

Interventions

Implant overdenture PROCEDURE

patients received implant overdenture

maxillary and mandibular implant overdenture; maxillary conventional denture and mandibular implant overdenture

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

• Moataz M. Elezaby, PhD student

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 31, 2024
• Study Start: January 10, 2022
• Primary Completion: September 15, 2023
• Study Completion: October 15, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)