Palatal Rugae Dentures: A New Way to Improve Satisfaction with Complete Dentures
Official title: The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life: A Randomized Crossover Clinical Trial
Run by Pakistan Institute of Medical Sciences · NCT07034079 · Data updated 2026-11-12
This study tests whether adding anatomically replicated palatal rugae to upper dentures improves satisfaction and jaw health-related quality of life for adults who are getting new complete dentures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Pakistan Institute of Medical Sciences Government |
| Locations | 1 site (Islamabad, Islamabad) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07034079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 45–80 who are completely edentulous, seeking first-time maxillary dentures, and able to attend follow-up visits.
✕Probably not a fit
Individuals with complex medical conditions, severe gag reflex, or long-standing denture wear history may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized crossover trial compares conventional smooth-palate complete maxillary dentures with dentures that incorporate anatomically replicated palatal rugae. The goal is to see if the rugae improve patient-reported satisfaction and oral health-related quality of life. Eligible participants are adults aged 45–80 who are edentulous and seeking first-time complete maxillary dentures. Outcomes will be measured through patient-reported questionnaires and follow-up assessments to determine functional and psychosocial impacts. The study is led by the Pakistan Institute of Medical Sciences with collaboration from SZABMU and the Shaheed Zulfiqar Ali Bhutto Medical University in Islamabad.
Why it matters
Potential benefit: If successful, patients could experience better comfort, speech, and overall satisfaction with their upper dentures.
How similar studies have gone: Some prior research suggests palatal anatomy can influence function, but results have varied, making this trial exploratory and informative.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 45-80 years. * Completely edentulous for at least 3 months. * Seeking new complete maxillary dentures for the first time. * Provided written informed consent * Motivated and compliant patients, willing to return for follow-up (helps reduce attrition bias) * Patients with Class I maxillomandibular relationship EXCLUSION CRITERIA * Patients with severe systemic diseases or neuromuscular dysfunction. * Presence of mental or auditory impairment. * History of oral pathology, xerostomia, or ankyloglossia (tied tongue). * Previous or experienced complete denture wearers. * Patient with strong gag reflex
Where it's running
-
School of Dentistry, SZABMU
Islamabad, Islamabad, 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.