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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01720420
Other study ID # T-174
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date December 2020

Study information

Verified date July 2018
Source Nobel Biocare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium with Locator attachment and related Overdenture on 4 NobelReplace implants with conical connection (CC) in the mandible/maxilla.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
NobelReplace CC, NobelProcera Implant Bar
Implants titanium with conical connection, individualized titanium bar

Locations

Country Name City State
Germany Guido Heydecke Hamburg
Germany Nikolaus and Alexandra Behneke Mainz
Italy Eugenio Romeo Milan
Italy Edoardo Stellini Padova
Italy Alessandro Pozzi Rome
Italy Università degli Studi di Sassari Sassari
Italy Marco Ferrari Siena

Sponsors (2)

Lead Sponsor Collaborator
Nobel Biocare Charite University, Berlin, Germany

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary MBL,marginal bone level change To evaluate and compare the clinical marginal bone level change (change MBL)in relation to defined implant reference point and different time points in the maxilla and mandible(between baseline at implant insertion and follow-up time points at 1 month, 6 month, 1 year, 2 year, 3 year and 5 year after implant insertion) of observation. 6 month, 1, 2, 3, 5 year
Secondary CSR implants CSR in % of placed implants 6 month, 1, 2, 3, 5 year
Secondary CSR prosthetics survival in % of placed final restorations 6 month, 1, 2, 3, 5 year
Secondary Gingival Status Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation. 6 month, 1, 2, 3, 5 year
Secondary Status of mucosa 0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized. 6 month, 1, 2, 3, 5 year,
Secondary Bleeding tendency (modified Sulcus Bleeding Index_mBI)(Mombelli):0 = No bleeding when a periodontal probe is passed along gingival margin adjacent to the implant.1 = Isolated bleeding spots visible. 2 = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding. 6 month, 1, 2, 3, 5 year
Secondary plaque accumulation modified Plaque Index (mPlI) (Mombelli):0 = No detectible plaque. 1 = Plaque only recognized by running a probe across the marginal surface of the implant. 2 = Plaque can be seen by the naked eye.3 = Abundance of soft matter 6 month, 1, 2, 3, 5 year
Secondary Pocket depths Pocket depths measured around implants in millimeter (mm) 6 month, 1, 2, 3, 5 year
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