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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04475913
Enrollment
56
Registered
2020-07-17
Start date
2018-07-11
Completion date
2020-08-20
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Mouth

Keywords

impressions, analogue, digital, All-on-Four

Brief summary

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.

Interventions

OTHERDIG Axial

patients received 4 axial implants and digital impression

OTHERDIG Tilted

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

OTHERCIG Axial

patients received 4 axial implants and conventional impression

OTHERCIG Tilted

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

Sponsors

October University for Modern Sciences and Arts
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
implant loss24 monthsThe 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

MeasureTime frameDescription
crestal bone loss24 monthsStandardized 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

MeasureTime frameDescription
maintenance24 monthsDuring 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026