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NCT Number: NCT05496283

Effect of Denture Adhesives on Complete Denture Patients

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

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Jordan

Amman, 11942, Jordan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

denture adhesive

Other

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

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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