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Clinical Trials/NCT05496283
NCT05496283
Completed
Not Applicable

The Effect of Using Denture Adhesives on Patient Satisfaction With Complete Dentures; A Randomized Clinical Trial

University of Jordan1 site in 1 country60 target enrollmentFebruary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complete Edentulism
Sponsor
University of Jordan
Enrollment
60
Locations
1
Primary Endpoint
oral health impact profile for edentulous patients (OHIP-EDENT)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial.

The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients

Detailed Description

Aims: The aims of this study is to compare patient satisfaction and oral health quality of life without using denture adhesive and using 3 types of denture adhesives. Materials and Methods: 60 completely edentulous patients attending the University of Jordan hospital seeking new sets of complete dentures will be randomly divided into 3 groups (n=20). At delivery of complete dentures, all patients will be given the dentures with no denture adhesive and will be given review appointments after one month of using the dentures. At review appointment, patients will be asked to rate their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also will fill out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group will then be given one type of denture adhesive to use; paste-based Corega denture adhesive (CO), Sea Bond maxillary and mandibular denture adhesive strips (SB) and oil-based Olivafix denture adhesive (OF). Patients will be given instructions on how to use each type of adhesive and will be provided with sufficient amount for 1 month. After 1 month, patients will be asked to fill out the same forms

Registry
clinicaltrials.gov
Start Date
February 10, 2022
End Date
February 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Nadia Ereifej

Associate Professor

University of Jordan

Eligibility Criteria

Inclusion Criteria

  • Patients seeking new conventional complete dentures for first time
  • Patients aged 40-85 years
  • Must be completely edentulous for at least 6 months
  • Must have well-developed to moderately resorbed maxillary and mandibular ridges
  • Must have no denture fissuratum or any traumas from previous dentures
  • Must be able to complete and sign the consent form

Exclusion Criteria

  • Patients with relevant medical issues, disorders of masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect response to treatment
  • Patients with oral pathology, xerostomia, or tied tongue condition.

Outcomes

Primary Outcomes

oral health impact profile for edentulous patients (OHIP-EDENT)

Time Frame: I month after denture delivery

20 aspects linking the dentures with patient quality of life, with a range of values from 1 to five for each aspect, with 1 being the best and 5 being the worst.

Patient satisfaction form

Time Frame: 1 month after denture delivery

10 aspects regarding patient satisfaction with dentures on 100mm visual analogue scale, with 0 value being completely unsatisfied and 100 for completely satisfied

Study Sites (1)

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