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

Edentulous Mouth Clinical Trial

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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475913
• Other study ID #: 5
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: August 20, 2020

Study information

• Verified date: July 2020
• Source: October University for Modern Sciences and Arts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 20, 2020
• Est. primary completion date: July 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Mouth
• Mouth, Edentulous

Intervention

Other:
• DIG Axial
patients received 4 axial implants and digital impression
• DIG Tilted
received two anterior axial implants and two distal tilted implants, and digital impression
• CIG Axial
patients received 4 axial implants and conventional impression
• CIG Tilted
received two anterior axial implants and two distal tilted implants, and conventional impression

Locations

Country	Name	City	State
Egypt	OctoberUMSA	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October University for Modern Sciences and Arts

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maintenance	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.	24 months
Primary	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	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