Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05468983 |
Other study ID # |
686 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 21, 2018 |
Est. completion date |
February 20, 2022 |
Study information
Verified date |
July 2022 |
Source |
Ain Shams University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The biggest challenge of oral rehabilitation is the replacement of lost structures and the
restoration of their function and esthetics, focusing on matching a healthy tooth.
Traditional complete dentures, implant (retained, supported) overdentures, and complete
implant-supported fixed prostheses are all alternatives to the rehabilitation of the
mandibular arch.
The aim of this study was to compare BioHPP used as a skeletal substructure for hybrid
(implant fixed, detachable) prostheses versus BioHPP bar supporting and retaining by using
radiographic tracing to the marginal bone height changes around the implants, patient
satisfaction can be improved.
Description:
Fourteen completely edentulous male patients were selected from the out-patient clinic,
Prosthodontic Department, Faculty of Dentistry, Ain Shams University, according to certain
criteria, and they were randomly allocated into two equal groups: group I: the seven patients
were rehabilitated by the BioHpp hybrid prosthesis supported on four inter-foraminal
implants; group II: While in group II, seven patients were rehabilitated by the BioHpp bar
supported and retained overdenture.
The upper and lower complete dentures were constructed following conventional methods, and
the surgical guide was constructed according to dual-scan CBCT.
the four parallel inter-foraminal implants were inserted in the mandible for each patient
through used the surgical guide ( flapless technique ) After three months from the first
surgery, the final prosthesis was constructed.
For Group I; BioHpp fixed hybrid prosthesis, for Group II; BioHpp bar implant-supported and
retained complete overdentures were created using digital workflow CAD/CAM.
The crestal bone height loss was evaluated after six, twelve, and eighteen months from
implant loading by using digital preapical radiography. Also, the patient's subjective
evaluations by using a questionnaire based on the visual analog scale including five points
(low dissatisfied, dissatisfied, fair, satisfied, highly satisfied) were evaluated for
speech, chewing, comfort aesthetic, oral hygiene, and general satisfaction.
A comparison between groups I and II was performed by using the Chi-square test, which
revealed in the results that group II was significantly lower than group I at all intervals
in the mesial and distal surfaces of anterior and posterior implants. Also, the results of
the patient satisfaction revealed that, after 6 months, there was an insignificant difference
between them as P > 0.05 in all except oral hygiene, as satisfaction was significantly higher
in group II than in group I. While, after 12 months, there was an insignificant difference
between them all (P > 0.05).