Effect of Denture Adhesives on Complete Denture Patients

Not Applicable

Completed

• Conditions: Complete Edentulism
• Interventions: Other: denture adhesive

• Registration Number: NCT05496283
• Lead Sponsor: University of Jordan

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

Study Timeline

• Study Start: 2022-02-10
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sea.Bond	denture adhesive	Complete denture patients given Sea.Bond denture adhesive.
OlivaFix	denture adhesive	Complete denture patients given OlivaFix denture adhesive.
Corega	denture adhesive	Complete denture patients given Corega denture adhesive.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The University of Jordan; 🇯🇴 Amman, Jordan