3D-printed Implant Overdentures

Sponsor

October University for Modern Sciences and Arts (Other)

Overall Status

Completed

CT.gov ID

NCT04569929

Collaborator

(none)

Enrollment

Location

Arms

19.3

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Edentulous Mouth	Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jun 5, 2020

Actual Study Completion Date :

Aug 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

. OHRQoL (oral health related quality of life) [12 months]
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.

Secondary Outcome Measures

Overdentures' retention [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Msa Uni	Giza		Egypt

Sponsors and Collaborators

October University for Modern Sciences and Arts

Investigators

Principal Investigator: Dina Elawady, PHD, MSA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina ElAwady, lecturer of Prosthodontics (principal investigator), October University for Modern Sciences and Arts

ClinicalTrials.gov Identifier:

NCT04569929

Other Study ID Numbers:

Modern Science and Art Uni

First Posted:

Sep 30, 2020

Last Update Posted:

Dec 16, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mouth, Edentulous

Study Results

No Results Posted as of Dec 16, 2020