- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01960361
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant (ICE)
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant System Over 24 Months, for Patients With Tooth Loss Requiring up to 4 Implants, in Staged Loading Protocol
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Rishon leZion, Israel, 70300
- Assaf Harofeh Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Men and women over the age of 18 years who need implantation of 1-4 implants.
- Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
- Patients who had provided written informed consent to participate in the study prior to any study procedure.
- Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.
Exclusion Criteria:
- Immediate loaded implants.
- Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
- Treatment with anticonvulsants drugs.
- Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
- Patients with history of alcohol, narcotics or drug abuse.
- Patients under steroid therapy.
Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.
Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
- Metabolic bone disorders and/or bone augmentation.
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
- Degenerative diseases.
- Osteoradionecrosis.
- Renal failure.
- Organ transplant recipients.
- HIV positive.
- Malignant diseases.
- Diseases that compromise the immune system.
- Unbalanced diabetes mellitus. (HbA1c above 6.5)
- Psychotic diseases.
- Hypersensitivity to one of the components of the implant in general and titanium in particular.
- Women who are pregnant or lactating.
- Lack of patient cooperation.
- Uncontrolled endocrine diseases.
- Any systemic condition that is unbalanced and therefore precludes surgical procedures.
- Parafunctional habits.- e.g Bruxism.
- Temporomandibular joint disease.
Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus ,malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: ICE dental implant
Subjects implanted with ICE implant
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ICE- Implant Classical Esthetic implant
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cumulative Survival Rate
Tidsramme: 24 MONTHS
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24 MONTHS
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICE_001
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