Evaluation of Digital 3D Printed Temporary Removable Partial Denture.
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
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2023
CompletedFirst Submitted
Initial submission to the registry
October 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedOctober 30, 2023
October 1, 2023
1.2 years
October 24, 2023
October 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
The conventional heat pressing temporary flexible maxillary removable partial denture
ACTIVE COMPARATOR3D-printed and digitally designed temporary flexible maxillary removable partial denture .
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry , Cairo university
Giza, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD student in prosthodontics department
Study Record Dates
First Submitted
October 24, 2023
First Posted
October 30, 2023
Study Start
June 2, 2023
Primary Completion
August 2, 2024
Study Completion
August 30, 2024
Last Updated
October 30, 2023
Record last verified: 2023-10