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

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Jaw
• Intervention / Treatment: Device: Conventional denture; Device: Maxillary open-faced denture

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional denture	Device: Conventional 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.
Experimental: maxillary open-faced denture	Device: Maxillary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 45 days
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.	up to 45 days
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.	up to 45 days

Collaborators and Investigators

• Sponsor: haitham ahmed hassan ismail
• Investigators: Principal Investigator: Haitham A Ismail, MSc, Alexandria University; Study Chair: Ingy S Soliman, PhD, Alexandria University; Study Chair: Muhammed B El-Danasory, PhD, Alexandria University; Study Chair: Salma S Abolgheit, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prominent Premaxilla
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: 0672-04/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No