A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading
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
1 other identifier
interventional
168
1 country
9
Brief Summary
This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
November 15, 2024
CompletedNovember 15, 2024
March 1, 2024
3.7 years
April 21, 2011
July 3, 2023
September 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Marginal Bone Level Change
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.
Implant insertion and 12 months post implant insertion
Secondary Outcomes (7)
Marginal Bone Level Change
Implant insertion and 3 months post implant insertion
Implant Survival Rate
12 months after baseline, i.e., implant insertion
Implant Stability Assessed Clinically/Manually
At implant insertion
Implant Stability Using Resonance Frequency Analysis (RFA)
At implant insertion.
Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"
After implant insertion
- +2 more secondary outcomes
Study Arms (2)
Soft bone drilling protocol
EXPERIMENTALA soft bone drilling protocol will be used in bone quality 3 and 4
Standard drilling protocol
ACTIVE COMPARATORA standard drilling protocol will be used in bone quality 1 and 2
Interventions
OsseoSpeed TX dental implants, 6-17 mm
Eligibility Criteria
You may qualify if:
- Provision of informed consent
- Female/male aged 18 years and over
- History of edentulism in the study area of at least 3 months
- At least 4 months healing after last grafting procedure in the study area
- In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
- The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
- Deemed by the investigator to be suitable for one stage surgery
- Deemed by the investigator to be suitable for immediate loading
- Deemed by the investigator as likely to present an initially stable implant situation.
- Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.
You may not qualify if:
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathological processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Present alcohol and/or drug abuse
- Current need for bone grafting and/or augmentation in the planned implant area
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Studio Associato Maffei
Bari, Italy
Studio Dentistico Paolo Torrisi
Catania, 95125, Italy
Societa diMedicina Odontostomatologica Srl
Como, 22100, Italy
Dept. of Oral Sciences "S. Palazzi", University of Pavia
Pavia, 27100, Italy
Studio Dentistico
Perugia, 06038, Italy
La Scala & Partners Studio Associato
Pistoia, 51100, Italy
Studio Odontoiatrico
Roma, 00192, Italy
Studio Dentistico
Torino, 10143, Italy
Studio Polispecialistico di Odontoiatria
Udine, 33100, Italy
Results Point of Contact
- Title
- Manager of Global Clinical Reseach
- Organization
- Dentsply Sirona Implants
Study Officials
- PRINCIPAL INVESTIGATOR
Ruggero Rodriguez y Baena, Prof
University of Pavia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 22, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
November 15, 2024
Results First Posted
November 15, 2024
Record last verified: 2024-03