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

Pakistan Institute of Medical Sciences

Status and phase: Begins enrollment this month; Phase 2

Conditions: Edentulism

Treatments: Device: complete dentures

Study type: Interventional

Funder types: Other

Identifiers

NCT07034079

SOD/12345

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

with palatal rugae initially

Experimental group

Description:

Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period.

Treatment:

Device: complete dentures

without palatal rugae initially

Experimental group

Description:

Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.

Treatment:

Device: complete dentures