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NCT Number: NCT06209814

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

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.

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Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Denture retention

    Time frame: up to 45 days

    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.

  2. Patient satisfaction with esthetics

    Time frame: up to 45 days

    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.

  3. Patient satisfaction with comfort

    Time frame: up to 45 days

    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.

Sponsors and collaborators

Lead sponsor

haitham ahmed hassan ismail

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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