3D-printed Implant Overdentures

NCT ID: NCT04569929

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-10

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures

Group Type ACTIVE_COMPARATOR

(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture

Intervention Type OTHER

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

intervention

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

Group Type EXPERIMENTAL

(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture

Intervention Type OTHER

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

Interventions

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(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

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Dina ElAwady

lecturer of Prosthodontics (principal investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Elawady, PHD

Role: PRINCIPAL_INVESTIGATOR

MSA

Locations

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Msa Uni

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Modern Science and Art Uni

Identifier Type: -

Identifier Source: org_study_id