Study on Immediate Loading of Immediately Placed Single Implants.

Dental Implants Clinical Trial

Official title:

Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01107600
• Other study ID #: HSPFBF-NB-02
• Status: Withdrawn
• Phase: N/A
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2018
• Source: Hospital San Pietro Fatebenefratelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement.

Description:

The international literature supported the potential advantages offered by this approach, but indicated a higher risk when compared with immediate loading in healed ridges.

The hypothesis to demonstrate is an high success and survival rates of Nobel Active™ implants used in combination with Bio-Oss® material.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Single-tooth implant restorations in the aesthetic zone

Exclusion Criteria:

• Medical risk patient

• Smoking

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• Immediate implant and socket preservation
Implant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction.

Locations

Country	Name	City	State
Italy	Marco Tallarico	Rome
Italy	Odontoiatric center San Pietro Hospital, FBF	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Hospital San Pietro Fatebenefratelli	Geistlich Pharma AG, Nobel Biocare

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Atieh MA, Payne AG, Duncan WJ, Cullinan MP. Immediate restoration/loading of immediately placed single implants: is it an effective bimodal approach? Clin Oral Implants Res. 2009 Jul;20(7):645-59. doi: 10.1111/j.1600-0501.2009.01725.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability quote (ISQ) measurements.	Measured by Ostell® Mentor Device.	8 weeks
Secondary	Aesthetic Results and Patient Satisfaction	Bone crest level changes measured by standardized intraoral radiographs.	1 year