Effect of Denture Adhesives on Complete Denture Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Complete Edentulism

Intervention / Treatment
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* Other: denture adhesive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corega<br>Complete denture patients given Corega denture adhesive. | Other: denture adhesive<br>* 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<br>|
| Experimental: OlivaFix<br>Complete denture patients given OlivaFix denture adhesive. | Other: denture adhesive<br>* 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<br>|
| Experimental: Sea.Bond<br>Complete denture patients given Sea.Bond denture adhesive. | Other: denture adhesive<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complete dentures, Patient satisfaction, denture adhesives