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

NCT ID: NCT06209814

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-05

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional denture

Group Type ACTIVE_COMPARATOR

Conventional denture

Intervention Type 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

Group Type EXPERIMENTAL

Maxillary open-faced denture

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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haitham ahmed hassan ismail

OTHER

Sponsor Role lead

Responsible Party

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haitham ahmed hassan ismail

Assistant Lecturer of Prosthodontics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Haitham A Ismail, MSc

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Ingy S Soliman, PhD

Role: STUDY_CHAIR

Alexandria University

Muhammed B El-Danasory, PhD

Role: STUDY_CHAIR

Alexandria University

Salma S Abolgheit, PhD

Role: STUDY_CHAIR

Alexandria University

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0672-04/2023

Identifier Type: -

Identifier Source: org_study_id

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