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3D-printed Implant Overdentures

O

October University for Modern Sciences and Arts

Status

Completed

Conditions

Edentulous Mouth

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04569929
Modern Science and Art Uni

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

60 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

14 participants in 2 patient groups

control
Active Comparator group
Description:
conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures
Treatment:
Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture
intervention
Experimental group
Description:
digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures
Treatment:
Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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