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

NCT06209814 | Completed

• 1 other identifier: 0672-04/2023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Jaw

Keywords

Prominent Premaxilla

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Conventional denture

ACTIVE COMPARATOR

Device: Conventional denture

maxillary open-faced denture

EXPERIMENTAL

Device: Maxillary open-faced denture

Interventions

Conventional denture DEVICE

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.

Conventional denture

Maxillary open-faced denture DEVICE

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.

maxillary open-faced denture

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• haitham ahmed hassan ismail: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Haitham A Ismail, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Ingy S Soliman, PhD

  Alexandria University

  STUDY CHAIR

• Muhammed B El-Danasory, PhD

  Alexandria University

  STUDY CHAIR

• Salma S Abolgheit, PhD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Prosthodontics

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: October 1, 2022
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (1)