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

Официальное название

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

Обзор

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.

Подробное описание

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. This study aims to evaluate whether incorporating palatal rugae can improve patient satisfaction and oral health-related quality of life when compared to conventional dentures with a smooth palatal surface.

By assessing patient-reported outcomes in a controlled and systematic manner, this research will contribute valuable evidence toward optimizing complete denture design for better functional and psychological outcomes in edentulous patients.

OBJECTIVE

• To compare conventional complete maxillary dentures with a smooth, polished palatal surface to those incorporating anatomical palatal rugae, in terms of patient-reported outcomes and oral health-related quality of life.

Вмешательства

• Устройство complete 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.

Первичные конечные точки

• General satisfaction [Срок оценки: 2 months]

Вторичные конечные точки (1)

• Satisfaction with eating, taste, speech, phonetics, ease of cleaning [Срок оценки: 2 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• School of Dentistry, SZABMU — Islamabad

Идентификаторы

NCT: NCT07034079 · SOD/12345

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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