search
Back to results

3D-printed Implant Overdentures

Primary Purpose

Edentulous Mouth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture
Sponsored by
October University for Modern Sciences and Arts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Mouth

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Msa Uni

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

intervention

Arm Description

conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures

digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures

Outcomes

Primary Outcome Measures

. 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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2020
Last Updated
December 14, 2020
Sponsor
October University for Modern Sciences and Arts
search

1. Study Identification

Unique Protocol Identification Number
NCT04569929
Brief Title
3D-printed Implant Overdentures
Official Title
Clinical Evaluation of Implant Overdentures Fabricated Using 3D -Printing Technology Versus Conventional Fabrication Technique: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October University for Modern Sciences and Arts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures
Arm Title
intervention
Arm Type
Experimental
Arm Description
digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures
Intervention Type
Other
Intervention Name(s)
(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture
Intervention Description
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
Primary Outcome Measure Information:
Title
. OHRQoL (oral health related quality of life)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overdentures' retention
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Elawady, PHD
Organizational Affiliation
MSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Msa Uni
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

3D-printed Implant Overdentures

We'll reach out to this number within 24 hrs