Palatal rugae designs for upper dentures and patient comfort
The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Dow University of Health Sciences Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07579377 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Karachi, Sindh
- Dow University of Health Sciences, Karachi — Karachi, Sindh, Pakistan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.