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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (CIG Axial) | Active Comparator | received 4 axial implants and conventional impression |
|
| (DIG Axial) | Experimental | received 4 axial implants and digital impression |
|
| CIG Tilted | Active Comparator | received two anterior axial implants and two distal tilted implants, and conventional impression |
|
| (DIG Tilted) | Experimental | received two anterior axial implants and two distal tilted implants, and digital impression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIG Axial | Other | patients received 4 axial implants and digital impression |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
participants were excluded if
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| Name | Affiliation | Role |
|---|---|---|
| Dina Elawady | Lecturer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OctoberUMSA | Giza | 12451 | Egypt |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| DIG Tilted | Other | received two anterior axial implants and two distal tilted implants, and digital impression |
|
| CIG Axial | Other | patients received 4 axial implants and conventional impression |
|
| CIG Tilted | Other | received two anterior axial implants and two distal tilted implants, and conventional impression |
|
| 24 months |
| 24 months |