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

NCT ID: NCT07034079

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

with palatal rugae initially

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

Group Type: EXPERIMENTAL

complete dentures

Intervention Type: DEVICE

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.

without palatal rugae initially

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

Group Type: EXPERIMENTAL

complete dentures

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

School of dentistry

UNKNOWN

Sponsor Role: collaborator

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chawla Rashmi

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SOD/12345

Identifier Type: -

Identifier Source: org_study_id