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

Study Overview
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Brief Summary
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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.

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

Conditions
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Edentulous Mouth

Intervention / Treatment
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* Other: DIG Axial
* Other: DIG Tilted
* Other: CIG Axial
* Other: CIG Tilted


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (CIG Axial)<br>received 4 axial implants and conventional impression | Other: DIG Axial<br>* patients received 4 axial implants and digital impression<br>|
| Experimental: (DIG Axial)<br>received 4 axial implants and digital impression | Other: DIG Tilted<br>* received two anterior axial implants and two distal tilted implants, and digital impression<br>Other: CIG Axial<br>* patients received 4 axial implants and conventional impression<br>|
| Active Comparator: CIG Tilted<br>received two anterior axial implants and two distal tilted implants, and conventional impression | Other: DIG Tilted<br>* received two anterior axial implants and two distal tilted implants, and digital impression<br>|
| Experimental: (DIG Tilted)<br>received two anterior axial implants and two distal tilted implants, and digital impression | Other: DIG Axial<br>* patients received 4 axial implants and digital impression<br>Other: CIG Tilted<br>* received two anterior axial implants and two distal tilted implants, and conventional impression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant loss | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| crestal bone loss | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impressions, analogue, digital, All-on-Four