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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06106243
Enrollment
13
Registered
2023-10-30
Start date
2023-06-02
Completion date
2024-08-30
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREThe 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

PROCEDURE3D-printed and digitally designed temporary flexible maxillary removable partial denture

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactMedhat Abdelaziz, MSC
dr.medhatsameh@gmail.com00201094023661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026