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OpenTrials
Completed

NCT Number: NCT04475913

Digital vs Analog Impression in Cases of All-on-4 - Prosthesis

Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants.

All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OctoberUMSA

Giza, 12451, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • completely edentulous patients with age range from 50-65 years.
  • physically and psychologically eligible participants for implants placement.
  • adequate bone to receive 4 interforaminal implants.

Exclusion criteria

participants were excluded if

  • medical conditions that precludes implants placement
  • smokers
  • patients suffering from any parafunctional habits

Treatment and study plan

DIG Axial

Other

patients received 4 axial implants and digital impression

DIG Tilted

Other

received two anterior axial implants and two distal tilted implants, and digital impression

CIG Axial

Other

patients received 4 axial implants and conventional impression

CIG Tilted

Other

received two anterior axial implants and two distal tilted implants, and conventional impression

Primary outcomes

  1. implant loss

    Time frame: 24 months

    The implants were considered surviving if they were clinically stable and functioning without any mobility. Failure was defined removal of implants due to loss of integration, pain, implant mobility, paraesthesia, neuropathies or psychological reasons. Calculation of the estimated failure rate was performed by dividing the number of implant failures by the total exposure time of the implant. The total exposure time is the interval of time the implants could be followed for the entire observation time or up to failure of the implants that were lost during the follow-up period.

Secondary outcomes

  1. crestal bone loss

    Time frame: 24 months

    Standardized periapical radiographs with long cone paralleling technique using film holders were used for the assessment of crestal bone loss. The loss of marginal bone relative to the implant shoulder at the mesial and distal of each implant was measured in mm and then the mean was calculated and statistically estimated. A digital intraoral imaging system was used (Digora phosphor plate reader, Soredex Tuusula, Finland). All the radiographs were scanned and then uploaded into the computer for assessing bone loss over time. The "ImageJ" software was used to take the measurements on the computer screen. Postoperative radiographs with the implants placed at the crest of the bone were compared with the 6,12 and 24 m radiographs.

Other outcomes

  1. maintenance

    Time frame: 24 months

    During the follow-up period, prosthodontic (mechanical) complications for the four groups were registered and calculated according to the following events: number of screw loosening or screw fracture of the abutment, number of screw loosening or screw fracture of the prosthesis, number of framework fracture, fractured acrylic resin, number of prosthetic teeth fracture and loss of cover of access hole.

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2020
Registry last updated
Mar 1, 2021

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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