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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04475913
Other study ID # 5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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