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

Not Applicable

Completed

• Conditions: Edentulism
• Interventions: Device: OsseoSpeed TX

• Registration Number: NCT01340170
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2023-07-03
• Status Verified: 2024-03
• Results First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Results First Posted: 2024-11-15
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard drilling protocol	OsseoSpeed TX	A standard drilling protocol will be used in bone quality 1 and 2
Soft bone drilling protocol	OsseoSpeed TX	A soft bone drilling protocol will be used in bone quality 3 and 4

Primary Outcome Measures

Name	Time	Method
Marginal Bone Level Change	Implant insertion and 12 months post implant insertion	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

Name	Time	Method
Marginal Bone Level Change	Implant insertion and 3 months post implant insertion	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 Survival Rate	12 months after baseline, i.e., implant insertion	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.
Implant Stability Assessed Clinically/Manually	At implant insertion	Evaluated clinically/manually and recorded as stable yes/no.
Implant Stability Using Resonance Frequency Analysis (RFA)	At implant insertion.	The Osstell® instrument "Osstell® ISQ" will be used to measure RFA. RFA measures the frequency with which a device vibrates. By comparing resonance frequencies the stability of a dental implant can be determined as the resonance frequency changes with different stability. The Osstell® ISQ instrument translates the RFA value into an Implant Stability Quotient (ISQ) scale value. ISQ is a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro mobility, with a higher value corresponding to increased stability.
Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"	After implant insertion	After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"	After implant insertion	After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.
Perception During Implant Insertion - "The Implant Has a Good Primary Stability"	After implant insertion	After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

Trial Locations

Locations (8)

Studio Associato Maffei; 🇮🇹 Bari, 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; 🇮🇹 Torino, Italy

La Scala & Partners Studio Associato; 🇮🇹 Pistoia, Italy

Studio Odontoiatrico; 🇮🇹 Roma, Italy

Studio Polispecialistico di Odontoiatria; 🇮🇹 Udine, Italy