Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture

NCT06109519 | Completed

• 1 other identifier: A0208023RP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments

Conditions

Prosthesis User

Outcome Measures

Primary Outcomes (2)

• crestal cone loss

  Intraoral radiographs were performed using the long cone paralleling technique to evaluate crestal bone loss

  three years

• prosthetic complications

  prosthetic complications were scored clinically

  three years

Study Arms (2)

Group I

ACTIVE COMPARATOR

patients who would be delivered a mandibular implant overdenture using conventional locator attachments.

Procedure: implant supported overdenture

Group II (study)

ACTIVE COMPARATOR

patients who would be delivered mandibular implant overdenture using Locator RTX attachments

Procedure: implant supported overdenture

Interventions

implant supported overdenture PROCEDURE

patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments

Group I; Group II (study)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All selected patients have two implants placed in the mandibular interforaminal region.
• \. All selected patients have a healthy mucosa and with no clinical complications.
• \. All patients are cooperative and approve the proposed treatment protocol

You may not qualify if:

• \. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University ,Faculty of dentistry

Al Mansurah, P.O.Box:35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients in this study will be divided into two equal groups Group I (control): patients who would be delivered mandibular implant overdenture using conventional locator attachments. Group II (study): patients who would be delivered mandibular implant overdenture using Locator RTX attachments

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: February 16, 2020
• Primary Completion: June 7, 2022
• Study Completion: September 16, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)