RecruitingNot Applicable

The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life

Pakistan90 participantsStarted 2025-10-20

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Patients with severe underlying medical conditions and mental conditions.
. Neuromuscular dysfunction.
. Oral diseases such as denture stomatitis and oral submucous fibrosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures

Timeframe: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months

Trial details

NCT IDNCT07579377

SponsorDow University of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Edentulism trials