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

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209814
• Other study ID #: 0672-04/2023
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 5, 2023

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
haitham ahmed hassan ismail

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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