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

Sponsor
Dentsply Sirona Implants (Industry)
Overall Status
Completed
CT.gov ID
NCT01340170
Collaborator
(none)
202
Enrollment
8
Locations
2
Arms
44
Actual Duration (Months)
25.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: OsseoSpeed TX
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
202 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Soft bone drilling protocol

A soft bone drilling protocol will be used in bone quality 3 and 4

Device: OsseoSpeed TX
OsseoSpeed TX dental implants, 6-17 mm
Active Comparator: Standard drilling protocol

A standard drilling protocol will be used in bone quality 1 and 2

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

Outcome Measures

Primary Outcome Measures

  1. Marginal bone level [12 months after baseline]

    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.

Secondary Outcome Measures

  1. Marginal Bone Level [3 months after baseline]

    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.

  2. Implant survival [12 months after baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Studio Dentistico Paolo Torrisi Catania Italy 95125
2 Societa diMedicina Odontostomatologica Srl Como Italy 22100
3 Dept. of Oral Sciences "S. Palazzi", University of Pavia Pavia Italy 27100
4 Studio Dentistico Perugia Italy 06038
5 La Scala & Partners Studio Associato Pistoia Italy 51100
6 Studio Odontoiatrico Roma Italy 00192
7 Studio Dentistico Torino Italy 10143
8 Studio Polispecialistico di Odontoiatria Udine Italy 33100

Sponsors and Collaborators

  • Dentsply Sirona Implants

Investigators

  • Principal Investigator: Ruggero Rodriguez y Baena, Prof, University of Pavia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dentsply Sirona Implants
ClinicalTrials.gov Identifier:
NCT01340170
Other Study ID Numbers:
  • YA-OTX-0002
First Posted:
Apr 22, 2011
Last Update Posted:
Aug 23, 2017
Last Verified:
Aug 1, 2017

Study Results

No Results Posted as of Aug 23, 2017