Evaluation of Digital 3D Printed Temporary Removable Partial Denture.

NCT ID: NCT06106243

Last Updated: 2023-10-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2024-08-30

Brief Summary

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This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.

Detailed Description

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Conditions

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Partial-edentulism Temporary Partial Denture 3D Printing Oral Health Related Quality of Life

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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The conventional heat pressing temporary flexible maxillary removable partial denture

Group Type ACTIVE_COMPARATOR

The conventional heat pressing temporary flexible maxillary removable partial denture

Intervention Type PROCEDURE

An intraoral scan will be made for each patient's maxillary and mandibular jaws in addition to digital bite registration using (Medit i700; Medit corp.) the resultant data will be exported in the form of a Standard Tessellation Language (STL) file. The denture base and the teeth will be designed using computer-aided design software (Partial Cad, Dental CAD software). Each patient will receive two RDPs, fabricated with two different manufacturing techniques. Based on randomization, the patients will start by receiving either partial denture that is fabricated by conventional heat pressing technique of 3D printed castable resin (Cast V1resin) followed by partial denture that is fabricated by 3D printing of printable resin (Flexo denture base, resin) and teeth (permanent crown,resin) or the other way around. In 3D-printed RDP, the artificial teeth will be attached to the fabricated denture bases using printable denture base resin material

3D-printed and digitally designed temporary flexible maxillary removable partial denture .

Group Type EXPERIMENTAL

3D-printed and digitally designed temporary flexible maxillary removable partial denture

Intervention Type PROCEDURE

3D-printed and digitally designed temporary flexible maxillary removable partial denture

Interventions

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The conventional heat pressing temporary flexible maxillary removable partial denture

An intraoral scan will be made for each patient's maxillary and mandibular jaws in addition to digital bite registration using (Medit i700; Medit corp.) the resultant data will be exported in the form of a Standard Tessellation Language (STL) file. The denture base and the teeth will be designed using computer-aided design software (Partial Cad, Dental CAD software). Each patient will receive two RDPs, fabricated with two different manufacturing techniques. Based on randomization, the patients will start by receiving either partial denture that is fabricated by conventional heat pressing technique of 3D printed castable resin (Cast V1resin) followed by partial denture that is fabricated by 3D printing of printable resin (Flexo denture base, resin) and teeth (permanent crown,resin) or the other way around. In 3D-printed RDP, the artificial teeth will be attached to the fabricated denture bases using printable denture base resin material

Intervention Type PROCEDURE

3D-printed and digitally designed temporary flexible maxillary removable partial denture

3D-printed and digitally designed temporary flexible maxillary removable partial denture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
* Fully dentulous or partially edentulous opposing mandibular arch.
* Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
* Age range (30-55 years).
* Cooperative patients that are willing to attend all follow-up periods.
* Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
* Patients with healthy abutments and healthy periodontium and no more than grade I mobility.

Exclusion Criteria

* Patients with Parkinson's disease
* Patients with xerostomia.
* Patients with a history of allergy to dentures made of resins.
* Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
* Patients with large irregular bony exostosis.
* Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Medhat Sameh Shehata Abdelaziz

PHD student in prosthodontics department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of dentistry , Cairo university

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Medhat Abdelaziz, MSC

Role: CONTACT

00201094023661

Facility Contacts

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Medhat Abdelaziz, MSC

Role: primary

00201094023661

Other Identifiers

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7-7-23

Identifier Type: -

Identifier Source: org_study_id

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