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Recruiting NCT06721377

Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

No phase Interventional Edentulism in Lower Jaw Edentulism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Novaloc attachment, Equator attachment.
Who it may be relevant to
Registry conditions: Edentulism in Lower Jaw, Edentulism. Basic parameters: 65 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Novaloc attachment
    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 \& will be loaded by Novaloc attachment.
  • Procedure Equator attachment
    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\& will be loaded by Equator attachment.

Primary outcome measures

  • Radiographic evaluation of bone height [Time frame: at baseline, 6 and 12 months]
  • Radiographic evaluation of bone density [Time frame: at baseline, 6 and 12 months]
Secondary outcome measures (1)
  • Pocket depth [Time frame: at baseline, 6 and 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dental Medicine , Al Azhar Univeristy For Girls — Cairo

Identifiers

NCT: NCT06721377 · REC al azhar university

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗