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

Primary Purpose

Edentulous Mouth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
DIG Axial
DIG Tilted
CIG Axial
CIG Tilted
Sponsored by
October University for Modern Sciences and Arts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Mouth focused on measuring impressions, analogue, digital, All-on-Four

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OctoberUMSA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

(CIG Axial)

(DIG Axial)

CIG Tilted

(DIG Tilted)

Arm Description

received 4 axial implants and conventional impression

received 4 axial implants and digital impression

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 14, 2020
Last Updated
February 24, 2021
Sponsor
October University for Modern Sciences and Arts
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1. Study Identification

Unique Protocol Identification Number
NCT04475913
Brief Title
Digital vs Analog Impression in Cases of All-on-4 - Prosthesis
Official Title
In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
July 11, 2020 (Actual)
Study Completion Date
August 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
October University for Modern Sciences and Arts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth
Keywords
impressions, analogue, digital, All-on-Four

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(CIG Axial)
Arm Type
Active Comparator
Arm Description
received 4 axial implants and conventional impression
Arm Title
(DIG Axial)
Arm Type
Experimental
Arm Description
received 4 axial implants and digital impression
Arm Title
CIG Tilted
Arm Type
Active Comparator
Arm Description
received two anterior axial implants and two distal tilted implants, and conventional impression
Arm Title
(DIG Tilted)
Arm Type
Experimental
Arm Description
received two anterior axial implants and two distal tilted implants, and digital impression
Intervention Type
Other
Intervention Name(s)
DIG Axial
Intervention Description
patients received 4 axial implants and digital impression
Intervention Type
Other
Intervention Name(s)
DIG Tilted
Intervention Description
received two anterior axial implants and two distal tilted implants, and digital impression
Intervention Type
Other
Intervention Name(s)
CIG Axial
Intervention Description
patients received 4 axial implants and conventional impression
Intervention Type
Other
Intervention Name(s)
CIG Tilted
Intervention Description
received two anterior axial implants and two distal tilted implants, and conventional impression
Primary Outcome Measure Information:
Title
implant loss
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
crestal bone loss
Description
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.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
maintenance
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Elawady
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
OctoberUMSA
City
Giza
ZIP/Postal Code
12451
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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