Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction

NCT06678945 | Active Not Recruiting DMC

• 1 other identifier: 27 4 24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment. Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)

Conditions

Edentulous Alveolar Ridge; Complete Edentulism; Dental Implant; Attachments; Implant Supported Overdenture; Edentulous Mouth; Edentulous Jaw

Keywords

Dental Implants; Completely edentulous patients; Edentulous Ridge

Outcome Measures

Primary Outcomes (1)

• Retention

  Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline. Measurement of mandibular denture retention: The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded.

  it will be measured at denture insertion, 3 month, and 6 month later

Secondary Outcomes (1)

• Patient satisfaction

  it will be measured at denture insertion, 3 month, and 6 month later.

Study Arms (2)

Bar-Clip attachment

ACTIVE COMPARATOR

on the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture

Procedure: Bar-Clip attachment

Bar- OT Equator attachment

EXPERIMENTAL

on the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture

Procedure: Bar- OT Equator attachment

Interventions

Bar-Clip attachment PROCEDURE

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.

Bar-Clip attachment

Bar- OT Equator attachment PROCEDURE

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.

Bar- OT Equator attachment

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients age must range from 60- 70 years old.
• All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
• Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
• All patients must have sufficient inter arch space

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Cairo University

Giza, Al Saraya, Old Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous; Jaw, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Jaw Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: May 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start Date: After publication End Date: 10 years
• Access Criteria: After publication through the corresponding author

Locations

EG (1)