To Evaluate the Complete Mandibular Dentures Produced Via 3D Printing in Comparison to Those Constructed From Metal-reinforced Acrylic Resin Regarding Their Retention

NCT07061860 | Completed

• 1 other identifier: 8887082022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures

Conditions

Edentulous Alveolar Ridge

Keywords

digital denture; retention; metal reinforced denture

Outcome Measures

Primary Outcomes (1)

• retention measurement

  To assess retention, a digital force gauge (Digital Force Gauge EXTECH 475044) was employed. All of the mandibular dentures were modified to receive a custom-made metal framework consisting of three tubes connected by a hook at the determining geometric center of the denture, two tubes extend 2 cm above the occlusal plane from the retromolar pad region, and one was made at the midline region lingual and below the central incisors. The mandibular denture's polished surface was then joined to the specially constructed custom-made metal framework using self-curing acrylic resin

  immediatlly after denture construction

Study Arms (2)

complete edentulous patient receive 3D printed denture

EXPERIMENTAL

group 1: 10 patients: Complete dentures constructed from poly-methyl methacrylate resin were used to create the mandibular and maxillary 3D-printed dentures

Device: digital complete denture

complete edentulous patient receive metal reinforced denture

ACTIVE COMPARATOR

group 2: 10 patients: complete denture constructed from metal reinforced acrylic denture

Device: metal reinforced complete denture

Interventions

digital complete denture DEVICE

different method of denture construction

complete edentulous patient receive 3D printed denture

metal reinforced complete denture DEVICE

different method of denture construction

complete edentulous patient receive metal reinforced denture

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Class I maxillary-mandibular relationship
• well-maintained oral mucosa
• normal salivary flow

You may not qualify if:

• smokers patient
• patient had any abnormalities in hard or soft tissues
• severe ridge undercut
• patient received radiation therapy to the head and neck region

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Resaerch Center

Cairo, 11553, Egypt

Location

Study Officials

• Ayman F Elawady, Ass prof

  National research center, cairo, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinding to patient and operator in intervention from begining
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor in Prosthodontics Department, Oral and Dental Research Institution, National Research Centre, Cairo, Egypt.

Model Details: randomozied controlled parallel double blinding study

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: July 7, 2022
• Primary Completion: January 7, 2024
• Study Completion: January 7, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)