Effect of Denture Adhesives on Complete Denture Patients

Complete Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496283
• Other study ID #: NSEreifej
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Other:
• denture adhesive
After 1 month of using the complete denture with no denture adhesives, patients fill up satisfaction and quality of life forms and given 1 of 3 types of denture adhesive to use for month to compare satisfaction and quality of life forms

Locations

Country	Name	City	State
Jordan	The University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction form	10 aspects regarding patient satisfaction with dentures on 100mm visual analogue scale, with 0 value being completely unsatisfied and 100 for completely satisfied	1 month after denture delivery
Primary	oral health impact profile for edentulous patients (OHIP-EDENT)	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.	I month after denture delivery