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Completed

NCT Number: NCT04366895

3D -Printed Single Implant Overdentures

A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Msa Uni

Giza, 12451, Egypt

About this study

Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.

Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the participant should be completely edentulous ranging in age from 35 to 75 years
  • Angle's class I skeletal relationship
  • normal facial symmetry
  • adequate inter-arch space not less than 12mm
  • should be a cooperative patient -

Exclusion criteria

  • temporomandibular disorders
  • uncontrolled diabetes
  • bleeding disorders or anticoagulant therapy
  • flabby tissues or sharp mandibular residual ridge
  • neuromuscular disorders
  • Angle's class II and III skeletal relationship.
  • Patients who were heavy smokers
  • chemotherapy or radiotherapy or with severe psychiatric disorders

Treatment and study plan

conventional single implant overdenture

Other

conventional manufactured implant overdenture

3d printed single implant overdenture

Other

CAD-CAM manufactured implant overdenture.

Primary outcomes

  1. Implant survival

    Time frame: 1 year

    The implants were considered surviving if they were clinically stable, functioning without any mobility

Secondary outcomes

  1. Survival rate of overdentures

    Time frame: 1 year

    urvival rate of overdentures: (calculated by Incidence of mid-line fracture)

  2. maximum biting force (MBF)

    Time frame: 1 year

    MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2020
Registry last updated
Nov 9, 2022

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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