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CompletedNCT06209814Updated Jan 18, 2024

Evaluation of Open-face Maxillary Complete Denture for Patients With Prominent Premaxilla

An interventional study of Conventional denture and Maxillary open-faced denture in Edentulous Jaw, sponsored by haitham ahmed hassan ismail. Completed at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by haitham ahmed hassan ismail · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2022, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study summary

The aim of the present study was to evaluate open faced maxillary complete denture with soft acryl resin wing versus conventional heat cured maxillary complete denture regarding the retention and patient satisfaction.

02

Conditions studied

  • Edentulous Jaw

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Keywords

  • Prominent Premaxilla
03

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 38 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

This is the only study on the registry with haitham ahmed hassan ismail as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completely edentulous male patients.
  • Patients having had no previous complete dentures
  • Patients with well-developed edentulous ridge with proclined premaxilla covered with healthy firm mucosa
  • Patients with normal Angle Class 1 maxillomandibular relationship

Exclusion criteria

Exclusion Criteria:

  • Patients with resorbed ridges
  • Patients with xerostomia and patients undertaking medications that affect salivary flow (e.g., diuretics). Similarly, patients with systemic diseases that may affect the amount or consistency of saliva (e.g., uncontrolled diabetes mellitus).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Active comparator
    Conventional denture

    Device: Conventional denture

  • Experimental
    maxillary open-faced denture

    Device: Maxillary open-faced denture

Interventions

  • DeviceConventional denture

    Patients in this group received conventional maxillary and mandibular complete dentures. The patients used these dentures for 45 days. Then, the conventional maxillary denture was replaced by open faced denture with soft acryl resin wing.

  • DeviceMaxillary open-faced denture

    Patients in this group received a maxillary open faced denture with soft acryl resin wing and a conventional mandibular complete denture. The patients used these dentures for 45 days. Afterward, the maxillary open-faced denture was replaced by one with a conventional construction.

06

What researchers measure

Primary outcomes

  1. Denture retention

    Evaluated using a universal testing machine to exert a vertical dislodging force on the denture. A stainless-steel loop was attached to the geometric center of the denture using autopolymerizing acrylic resin. The center of the labial frenum (point A) and the hamular notches (points B\&C) were located in the denture base. The distance halfway between points B and C was measured, and the location was marked on the posterior border of the denture base (point D). Half the distance between points A and D was marked as the denture base center (point E). A force transmission device was used to transmit the dislodging vertical force from the universal testing machine to the denture. A facebow was used to set the Frankfort plane of the patient parallel to the floor. After orienting the participant to the testing machine, it was set to exert a dislodging force at a rate of 50 mm/min. The test was repeated 3 times for each denture and the mean was calculated.

    Time frame: up to 45 days

  2. Patient satisfaction with esthetics

    Participant satisfaction with esthetics was evaluated by using a Visual Analogue Scale (VAS). The level of satisfaction was indicated as a sign on a 10 cm VAS, labeled with (not at all satisfied) at the zero end with (completely satisfied) at the other end. The distance (mm) between the zero point and the sign marked by the patient on the 10-cm-line was measured and expressed in percentage.

    Time frame: up to 45 days

  3. Patient satisfaction with comfort

    Participant satisfaction with comfort was evaluated by using a Visual Analogue Scale (VAS). The level of satisfaction was indicated as a sign on a 10 cm VAS, labeled with (not at all satisfied) at the zero end with (completely satisfied) at the other end. The distance (mm) between the zero point and the sign marked by the patient on the 10-cm-line was measured and expressed in percentage.

    Time frame: up to 45 days

07

Study locations

1 site
  • Faculty of Dentistry, Alexandria University
    Alexandria, 21527, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06209814
Lead sponsor
haitham ahmed hassan ismail
Responsible party
haitham ahmed hassan ismail (Assistant Lecturer of Prosthodontics, Alexandria University) — Sponsor-investigator
First posted
Jan 18, 2024
Start date
Oct 1, 2022
Primary completion
Oct 5, 2023
Completion
Oct 5, 2023
Last update
Jan 18, 2024

Study contacts

Haitham A Ismail, MSc
principal investigator · Alexandria University
Ingy S Soliman, PhD
study chair · Alexandria University
Muhammed B El-Danasory, PhD
study chair · Alexandria University
Salma S Abolgheit, PhD
study chair · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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