Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06721377

Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Edentulism in Lower Jaw Edentulism

Age range

65 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novaloc Attachment

Procedure

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.

Equator Attachment

Procedure

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 outcomes

  1. 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)

  2. 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

  1. Pocket depth

    Time frame: at baseline, 6 and 12 months

    Pocket depth will be measured using periodontal probe

Study contacts

Contact information is provided by the study sponsor or research team.

Sara H Kadry, masters

CONTACT

[email protected]

02-01226595217

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: Overdenture

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.