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Clinical Trials/NCT06721377
NCT06721377
Recruiting
Not Applicable

Clinical and Radiographic Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

Al-Azhar University1 site in 1 country10 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulism in Lower Jaw
Sponsor
Al-Azhar University
Enrollment
10
Locations
1
Primary Endpoint
Radiographic evaluation of bone height
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University..

Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or alternative management.

Detailed Description

All 10 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two groups, one group will be loaded by Novaloc attachment. While the other group will be loaded by Equator attachment. Implants will be functionally loaded after three months of insertion.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
January 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Hossam El-din Kadry Othman

Assistant lecturer

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
  • Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
  • All patients must have sufficient inter arch space.

Exclusion Criteria

  • Patients with oral or systemic diseases.
  • Patients with xerostomia or excessive salivation.
  • Patients with parafunctional habits (bruxism or clenching).
  • Heavy smoker or alcoholic patients.
  • Patients with history of temporo-mandibular dysfunction.
  • Patients with brain disorders or psychiatric disorders.

Outcomes

Primary Outcomes

Radiographic evaluation of bone height

Time Frame: at baseline, 6 and 12 months

Radiographic evaluation of bone height around each implant and at distal extension area will be evaluated using cone beam CT (CBCT)

Radiographic evaluation of bone density

Time Frame: at baseline, 6 and 12 months

Radiographic evaluation of bone density around implant and at distal extension area will be evaluated using cone beam CT (CBCT)

Secondary Outcomes

  • Pocket depth(at baseline, 6 and 12 months)

Study Sites (1)

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