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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT06109519
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
43
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: implant supported overdenture
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 attachmentsAll 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
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study
Actual Study Start Date :
Feb 16, 2020
Actual Primary Completion Date :
Jun 7, 2022
Actual Study Completion Date :
Sep 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I

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

Procedure: implant supported overdenture
patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments
Active Comparator: Group II (study)

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

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

Outcome Measures

Primary Outcome Measures

  1. crestal cone loss [three years]

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

  2. prosthetic complications [three years]

    prosthetic complications were scored clinically

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. All selected patients have two implants placed in the mandibular interforaminal region.

  1. All selected patients have a healthy mucosa and with no clinical complications.

  2. All patients are cooperative and approve the proposed treatment protocol

Exclusion Criteria:
    1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University ,Faculty of dentistry Mansoura Egypt P.O.Box:35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT06109519
Other Study ID Numbers:
  • A0208023RP
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 31, 2023