Clinical trial NCT01340170: A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulism
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.

Eligibility criteria: 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.

Primary outcomes:
measure: Marginal Bone Level Change
timeFrame: Implant insertion and 12 months post implant insertion
Secondary outcomes:
measure: Marginal Bone Level Change
timeFrame: Implant insertion and 3 months post implant insertion
measure: Implant Survival Rate
timeFrame: 12 months after baseline, i.e., implant insertion
measure: Implant Stability Assessed Clinically/Manually
timeFrame: At implant insertion
measure: Implant Stability Using Resonance Frequency Analysis (RFA)
timeFrame: At implant insertion.
measure: Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"
timeFrame: After implant insertion
measure: Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"
timeFrame: After implant insertion
measure: Perception During Implant Insertion - "The Implant Has a Good Primary Stability"
timeFrame: After implant insertion
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Studio Associato Maffei
city: Catania
country: Italy
facility: Studio Dentistico Paolo Torrisi
city: Como
country: Italy
facility: Societa diMedicina Odontostomatologica Srl
city: Pavia
country: Italy
facility: Dept. of Oral Sciences "S. Palazzi", University of Pavia
city: Perugia
country: Italy
facility: Studio Dentistico
city: Pistoia
country: Italy
facility: La Scala & Partners Studio Associato
city: Roma
country: Italy
facility: Studio Odontoiatrico
city: Torino
country: Italy
facility: Studio Dentistico
city: Udine
country: Italy
facility: Studio Polispecialistico di Odontoiatria
Study officials:
affiliation: University of Pavia
name: Ruggero Rodriguez y Baena, Prof
role: PRINCIPAL_INVESTIGATOR
References: