NCT07034079

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
5mo left

Started Jul 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 7, 2026

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 13, 2025

Last Update Submit

July 3, 2026

Conditions

Edentulism

Keywords

Palatal rugaeOral health impact profileEdentulismcomplete denture

Outcome Measures

Primary Outcomes (1)

  • General satisfaction

    VAS score comparison between palatal contours

    2 months

Secondary Outcomes (1)

  • Satisfaction with eating, taste, speech, phonetics, ease of cleaning

    2 months

Study Arms (2)

with palatal rugae initially

EXPERIMENTAL

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

Device: complete dentures

without palatal rugae initially

EXPERIMENTAL

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

Device: complete dentures

Interventions

complete denturesDEVICE

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.

with palatal rugae initiallywithout palatal rugae initially

Eligibility Criteria

Age40 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, SZABMU

Islamabad, Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Interventions

Denture, Complete

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 24, 2025

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 7, 2026

Record last verified: 2025-07

Locations

PA(1)