Palatal rugae designs for upper dentures and patient comfort
Official title: The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
Run by Dow University of Health Sciences · NCT07579377 · Data updated 2026-11-12
We will test three palatal surface designs in upper complete dentures to see if they improve comfort, chewing, speaking, and overall oral quality of life for adults without teeth aged 40 to 80.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Dow University of Health Sciences Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07579377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are edentulous adults aged 40–80 seeking conventional maxillary complete dentures who can attend the required follow-up visits and do not have the listed exclusion conditions.
✕Probably not a fit
Patients with severe medical or neuromuscular disorders, active oral diseases, xerostomia, tied tongue, or markedly flabby or atrophic ridges are unlikely to benefit from these palatal design changes.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 40–80 who need conventional maxillary complete dentures will receive one of three palatal designs: a polished palatal surface, a roughened palatal rugae surface, or a vacuum-formed thermoplastic sheet with rugae. Participants will receive their denture, then attend follow-up assessments at 1 week, 1 month, and 3 months (in person or by phone) to report satisfaction and oral health–related quality of life related to chewing, speech, and comfort. Outcomes will compare patient-reported satisfaction and functional measures across the three designs to identify whether textured or vacuum-formed rugae improve adaptation to the prosthesis. The trial is conducted at Dow University of Health Sciences in Karachi and excludes patients with significant medical, neuromuscular, or certain oral conditions that could affect denture use.
Why it matters
Potential benefit: If successful, a modified palatal design could make upper dentures feel more comfortable and improve chewing and speech for many denture wearers.
How similar studies have gone: Small studies and case reports have suggested textured palates or rugae patterns can aid tongue contact and comfort, but the evidence is limited and inconsistent.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Dow University of Health Sciences, Karachi
Karachi, Sindh, Pakistan Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.