A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

Edentulism Clinical Trial

Official title:

An Open, Non-randomized, Prospective Multi-centre Study Evaluating a Soft Bone Drilling Protocol for Single Tooth Restoration in the Posterior Area With Immediate Loading

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340170
• Other study ID #: YA-OTX-0002
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: August 22, 2017
• Start date: April 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to establish that there is no statistical difference in marginal bone level change comparing a Standard drilling protocol with a Soft bone drilling protocol when using OsseoSpeed TX and immediate loading.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of informed consent

2. Female/male aged 18 years and over

3. History of edentulism in the study area of at least 3 months

4. At least 4 months healing after last grafting procedure in the study area

5. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47

6. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.

7. Deemed by the investigator to be suitable for one stage surgery

8. Deemed by the investigator to be suitable for immediate loading

9. Deemed by the investigator as likely to present an initially stable implant situation.

10. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

Exclusion Criteria

1. Unlikely to be able to comply with study procedures, as judged by the investigator

2. Uncontrolled pathological processes in the oral cavity

3. Known or suspected current malignancy

4. History of radiation therapy in the head and neck region

5. History of chemotherapy within 5 years prior to surgery

6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration

7. Uncontrolled diabetes mellitus

8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration

9. Present alcohol and/or drug abuse

10. Current need for bone grafting and/or augmentation in the planned implant area

11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)

12. Previous enrolment in the present study.

13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.

Related Conditions & MeSH terms

• Edentulism

Intervention

Device:
• OsseoSpeed TX
OsseoSpeed TX dental implants, 6-17 mm

Locations

Country	Name	City	State
Italy	Studio Dentistico Paolo Torrisi	Catania
Italy	Societa diMedicina Odontostomatologica Srl	Como
Italy	Dept. of Oral Sciences "S. Palazzi", University of Pavia	Pavia
Italy	Studio Dentistico	Perugia
Italy	La Scala & Partners Studio Associato	Pistoia
Italy	Studio Odontoiatrico	Roma
Italy	Studio Dentistico	Torino
Italy	Studio Polispecialistico di Odontoiatria	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone level	Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.	12 months after baseline
Secondary	Marginal Bone Level	Marginal Bone Level alterations will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.	3 months after baseline
Secondary	Implant survival	Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.	12 months after baseline