Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques

Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques of the Locator Retentive Caps for Two Implant-supported Mandibular Overdentures: A Crossover Study

This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture

Study Overview

• Status: Completed
• Conditions: Prosthesis User
• Intervention / Treatment: Procedure: implant supported mandibular overdenture

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, P.O.Box:35516
    • Mansoura University ,Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. All selected patients will have two implants placed in the mandibular interforaminal region.

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

  3. All patients are cooperative and approve of the proposed treatment protocol

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: • Group I; Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method.	Procedure: implant supported mandibular overdenture; In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.
Active Comparator: • Group II; Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method.	Procedure: implant supported mandibular overdenture; In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.
Active Comparator: Group III; Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method.	Procedure: implant supported mandibular overdenture; In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.
Active Comparator: Group IV; Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.	Procedure: implant supported mandibular overdenture; In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	patient satisfaction was recorded using score system on a scale from 0 to 100	One year
oral health related quality of life	Oral health related quality of life was evaluated by using scoring system	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A0108023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No