Evaluation of Digital 3D Printed Temporary Removable Partial Denture.

Study Overview
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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.

Official Title
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Oral Health-Related Quality of Life and Retention in Digitally Versus Conventionally Fabricated Flexible Removable Partial Dentures in Maxillary Class III Modification 1 Patients: A Cross-over Randomized Clinical Trial

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

Intervention / Treatment
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* Procedure: The conventional heat pressing temporary flexible maxillary removable partial denture
* Procedure: 3D-printed and digitally designed temporary flexible maxillary removable partial denture


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The conventional heat pressing temporary flexible maxillary removable partial denture<br> | Procedure: The conventional heat pressing temporary flexible maxillary removable partial denture<br>* 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<br>|
| Experimental: 3D-printed and digitally designed temporary flexible maxillary removable partial denture .<br> | Procedure: 3D-printed and digitally designed temporary flexible maxillary removable partial denture<br>* 3D-printed and digitally designed temporary flexible maxillary removable partial denture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life. | Oral health impact profile (OHIP 14) questionnaire will be used to asses the oral health-related quality of life | Baseline and 6 months | 
| Retention of a removable partial denture | The retention will be measured using Digital Force Gauge attached to the denture polished surface while the patient is in supine position | Baseline and 6 months |