RecruitingPhase 2NCT07034079

The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life

The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life: A Randomized Crossover Clinical Trial


Sponsor

Pakistan Institute of Medical Sciences

Enrollment

60 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

In conventional maxillary complete dentures, the palatal surface is typically smooth and polished, lacking the natural anatomy of the palatal rugae. While this design facilitates ease of cleaning, it may compromise the functional feedback required for speech and other oral functions. Since the palatal rugae contain mechanoreceptors essential for guiding the tongue during phonation and mastication, replicating these structures may enhance oral function and patient adaptation. Given the variation in clinical outcomes reported in prior studies, a randomized crossover clinical trial is warranted to assess the impact of adding anatomically replicated palatal rugae to complete dentures.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called complete dentures for people with edentulism. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEcomplete dentures

Participants were randomly allocated into two intervention sequences using a computer-generated randomization list. The two sequences were: * Group A: Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period. * Group B: Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.


Locations(1)

School of Dentistry, SZABMU

Islamabad, Islamabad, Pakistan

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NCT07034079


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