- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04475913
Digital vs Analog Impression in Cases of All-on-4 - Prosthesis
In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Giza, Egypt, 12451
- OctoberUMSA
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: (CIG Axial)
received 4 axial implants and conventional impression
|
patients received 4 axial implants and digital impression
|
Eksperimentell: (DIG Axial)
received 4 axial implants and digital impression
|
received two anterior axial implants and two distal tilted implants, and digital impression
patients received 4 axial implants and conventional impression
|
Aktiv komparator: CIG Tilted
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
|
Eksperimentell: (DIG Tilted)
received two anterior axial implants and two distal tilted implants, and digital impression
|
patients received 4 axial implants and digital impression
received two anterior axial implants and two distal tilted implants, and conventional impression
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
implant loss
Tidsramme: 24 months
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
crestal bone loss
Tidsramme: 24 months
|
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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
maintenance
Tidsramme: 24 months
|
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Dina Elawady, lecturer
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5
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