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Completed

NCT Number: NCT04569929

3D-printed Implant Overdentures

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.

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Key information

Conditions

Edentulous Mouth Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Msa Uni

Giza, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. . OHRQoL (oral health related quality of life)

    Time frame: 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 outcomes

  1. Overdentures' retention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2020
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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