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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Polished Palatal Surface Denture
DeviceMaxillary complete denture with a traditional polished palatal surface. Fabricated using standard clinical procedures without added rugae or texturing. Serves as the control design in this study and will be compared with roughened and vacuum-formed thermoplastic sheet dentures to assess patient satisfaction, comfort, chewing ability, and oral health-related quality of life.
Roughened Palatal Rugae Design
DeviceMaxillary complete denture with a roughened palatal rugae surface. Rugae are intentionally textured to enhance tactile feedback, retention, and comfort. Standard fabrication and fitting procedures are used. Compared with polished and vacuum-formed dentures to evaluate effects on patient satisfaction, comfort, chewing efficiency, and oral health-related quality of life.
Vacuum-Formed Thermoplastic Sheet Rugae Denture
DeviceMaxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns to improve denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting. Compared with polished and roughened dentures to assess patient satisfaction, comfort, and oral health-related quality of life.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Polished Palatal Surface DentureExperimental treatment 1 intervention
Group B: Arm 2: Roughened Palatal Rugae DesignExperimental treatment 1 intervention
Group C: Arm 3: Vacuum-Formed Thermoplastic Rugae DentureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures
Patient satisfaction with maxillary complete dentures assessed using a Visual Analog Scale (VAS). Participants rate their overall satisfaction on a 100-mm line, where 0 indicates "not satisfied" and 100 indicates "totally satisfied." Higher scores indicate greater satisfaction.
Time frame
From enrolment to the end of treatment at 1 week, 3 weeks, 3 monthsSecondary outcomes
1
Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.
Oral health-related quality of life will be assessed using the 20-item OHIP-EDENT questionnaire at 3 months post-insertion of complete dentures with polished, roughened, or vacuum-formed palatal rugae designs. Scores will range from 20 (best) to 100 (worst), with lower scores indicating better quality of life. This measure will evaluate the impact of different palatal rugae textures on patients' comfort, function, and overall oral health-related quality of life over time
Time frame
From enrolment to the end of treatment at 1 week, 3 weeks, 3 monthsSponsors and contacts
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Source ClinicalTrials.gov