Evaluation of Digital 3D Printed Temporary Removable Partial Denture.

Partial-edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106243
• Other study ID #: 7-7-23
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Medhat Abdelaziz, MSC
• Phone: 00201094023661
• Email: dr.medhatsameh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: August 30, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of dentistry , Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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