NCT07579377 The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
| NCT ID | NCT07579377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dow University of Health Sciences |
| Condition | Edentulism |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-10-20 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Patients seeking conventional complete dentures. 2. Aged 40-80 years. 3. Both genders (male and female). 4. Patient's must be willing to participate in the study and able to attend follow-up appointments Exclusion Criteria: 1. Patients with severe underlying medical conditions and mental conditions. 2. Neuromuscular dysfunction. 3. Oral diseases such as denture stomatitis and oral submucous fibrosis 4. Xerostomia and tied tongue condition. 5. Flabby and Atrophic Ridges.
Frequently Asked Questions
Who can join the NCT07579377 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Edentulism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07579377 currently recruiting?
Yes, NCT07579377 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dow University of Health Sciences to inquire about joining.
Where is the NCT07579377 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT07579377 clinical trial?
NCT07579377 is sponsored by Dow University of Health Sciences. The trial plans to enroll 90 participants.