Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control (denture)

May 1, 2024 updated by: Sharaf Mohamed Yahia, Cairo University

Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers.

Material and methods : 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11511
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • completely edentulous

Exclusion Criteria:

  • no

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: denture adhesive
use denture adhesive
Other: denture adhesive
use of adhesive for completely edentulous
Other Names:
  • use of adhesive for denture
Active Comparator: non adhesive
conventional denture without denture adhesive
Other: denture adhesive
use of adhesive for completely edentulous
Other Names:
  • use of adhesive for denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients satisfaction
Time Frame: 6 months
questionnaires
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

November 9, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6785/5
  • asharaf Email (Other Identifier: cairo university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental

Clinical Trials on denture adhesive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe