The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorDow University of Health Sciences
About this trial
The goal of this clinical trial is to learn whether different palatal rugae designs in complete dentures can improve comfort, function, and overall oral health-related quality of life in edentulous adults aged 40 to 80 years. The main questions it aims to answer are:
Do roughened or vacuum-formed thermoplastic sheet palatal rugae designs lead to higher patient satisfaction than the traditional polished design?
Do these designs improve oral health-related quality of life, including chewing, speaking, and overall comfort?
Researchers will compare three denture designs-a polished palatal surface, a roughened palatal surface, and a vacuum-formed thermoplastic sheet rugae design-to see which design provides better comfort, function, and quality of life for patients.
Participants will:
Receive complete maxillary dentures made with one of the three palatal rugae designs
Attend follow-up assessments at 1 week, 1 month, and 3 months after denture insertion (in person or by phone)
Complete the OHIP-EDENT questionnaire and a Visual Analog Scale (VAS) to report satisfaction, comfort, and oral health-related quality of life.
Eligibility criteria
Qualifiers
Patients seeking conventional complete dentures.
Aged 40-80 years.
Both genders (male and female).
Patient's must be willing to participate in the study and able to attend follow-up appointments
Disqualifiers
Patients with severe underlying medical conditions and mental conditions.
Neuromuscular dysfunction.
Oral diseases such as denture stomatitis and oral submucous fibrosis
Xerostomia and tied tongue condition.
Trial design
Treatments tested in this trial
- Polished Palatal Surface Denture
- Roughened Palatal Rugae Design
- Vacuum-Formed Thermoplastic Sheet Rugae Denture
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov