Evaluation of Digital 3D Printed Temporary Removable Partial Denture.

Not Applicable

Recruiting

• Conditions: Partial-edentulism; Temporary Partial Denture; 3D Printing; Oral Health Related Quality of Life
• Interventions: Procedure: 3D-printed and digitally designed temporary flexible maxillary removable partial denture; Procedure: The conventional heat pressing temporary flexible maxillary removable partial denture

• Registration Number: NCT06106243
• Lead Sponsor: Cairo University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-06-02
• Status Verified: 2023-10
• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-08-02
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3D-printed and digitally designed temporary flexible maxillary removable partial denture .	3D-printed and digitally designed temporary flexible maxillary removable partial denture	-
The conventional heat pressing temporary flexible maxillary removable partial denture	The conventional heat pressing temporary flexible maxillary removable partial denture	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of dentistry , Cairo university; 🇪🇬 Giza, Egypt