Clinical trial NCT05496283: Effect of Denture Adhesives on Complete Denture Patients
Official title: The Effect of Using Denture Adhesives on Patient Satisfaction With Complete Dentures; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Edentulism
Keywords: Complete dentures
Patient satisfaction
denture adhesives
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Patient satisfaction form
timeFrame: 1 month after denture delivery
measure: oral health impact profile for edentulous patients (OHIP-EDENT)
timeFrame: I month after denture delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
affiliation: The University of Jordan
name: Nadia Ereifej, PhD
role: PRINCIPAL_INVESTIGATOR
References: