3D-printed Implant Overdentures

Clinical Evaluation of Implant Overdentures Fabricated Using 3D -Printing Technology Versus Conventional Fabrication Technique: A Randomized Trial

A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.

Study Overview

• Status: Completed
• Conditions: Edentulous Mouth
• Intervention / Treatment: Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Msa Uni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• completely edentulous
• ranging in age from 50 to 65 years
• Angle's class I skeletal relationship, normal facial symmetry.
• Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
• appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures

Exclusion Criteria:Metabolic disorders affecting osseointegration such as hepatic disorders

• osteoporosis and diabetes mellitus.
• Temporomandibular disorders, anticoagulant therapy or bleeding disorders
• sharp mandibular residual ridge or flabby tissues
• neuromuscular disorders, and class II and III Angle's classification skeletal relationship
• Smokers and patients on chemotherapy or radiotherapy or suffering from psychiatric conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures	Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture; The bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space
Experimental: intervention; digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures	Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture; The bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. OHRQoL (oral health related quality of life)	Oral Health Impact Profile 19 (OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). The questionnaire was translated to Arabic and validated (S2).24 The profile consisted of 19 questions each with score 0 to 4 (impaired) on Likert scale; accordingly, for each patient the minimum score was 0 and maximum score was 76.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overdentures' retention	The retention was measured at baseline (day of delivery), three months thereafter, after six months then after 12m by a digital force gauge device (Extech's Model 475055 Digital Force Gauge FLIR Commercial Systems, Inc.) that measures tension or compression force (pull/push) to values of up to 980 Newton.25 The snap hook of the device engaged a screw fixed to the geometric center of denture bases using self-cure acrylic resin. Then pulling action was applied till the denture separation recording the amount of retention in Newton.	12 months

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts
• Investigators: Principal Investigator: Dina Elawady, PHD, MSA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 5, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: Modern Science and Art Uni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No