Recruiting PHASE2 Edentulism

New treatment option for Edentulism

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

ClinicalTrials.gov ID: NCT07034079

What this study is testing

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 40 to 80. Healthy volunteers may be eligible.

You may be able to join 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)

You likely can't join 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Islamabad, Islamabad, Pakistan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Islamabad, Islamabad, Pakistan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.