EdentulismNCT01340170

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

A study testing OsseoSpeed TX in people with Edentulism, run by Dentsply Sirona Implants and Consumables at 9 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Edentulism
What is being tested?: OsseoSpeed TX
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 168 participants
Where: 9 sitesItaly
Study dates: Apr 2011to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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

Show all 13Show fewer

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Italy9 sites

Studio Associato Maffei
Bari
Studio Dentistico Paolo Torrisi
Catania, 95125
Societa diMedicina Odontostomatologica Srl
Como, 22100
Dept. of Oral Sciences "S. Palazzi", University of Pavia
Pavia, 27100
Studio Dentistico
Perugia, 06038
La Scala & Partners Studio Associato
Pistoia, 51100
Studio Odontoiatrico
Roma, 00192
Studio Dentistico
Torino, 10143
Studio Polispecialistico di Odontoiatria
Udine, 33100

Other trials in Italy

About this study

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

Read the 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.

Conditions: Edentulism
Being tested: OsseoSpeed TX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OsseoSpeed TXDevice
OsseoSpeed TX dental implants, 6-17 mm

Study groups in NCT01340170
Study group	Role	What they receive
Soft bone drilling protocol	Experimental	A soft bone drilling protocol will be used in bone quality 3 and 4 Receives: Device: OsseoSpeed TX
Standard drilling protocol	Active comparator	A standard drilling protocol will be used in bone quality 1 and 2 Receives: Device: OsseoSpeed TX

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Implant insertion and 12 months post implant insertion

Secondary outcomes (7)

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.
Measured: Implant insertion and 3 months post implant insertion
Implant Survival Rate
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.
Measured: 12 months after baseline, i.e., implant insertion
Implant Stability Assessed Clinically/Manually
Evaluated clinically/manually and recorded as stable yes/no.
Measured: At implant insertion
Implant Stability Using Resonance Frequency Analysis (RFA)
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.
Measured: At implant insertion.
Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"
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.
Measured: After implant insertion
Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"
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.
Measured: After implant insertion
Perception During Implant Insertion - "The Implant Has a Good Primary Stability"
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.
Measured: After implant insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2014

First posted22 Apr 2011 (estimated)
Study startApr 2011
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EdentulismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340170
Sponsor's protocol ID: YA-OTX-0002
Status last verified: Mar 2024
First submitted: 21 Apr 2011
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multi-Evaluation of Dental Abutments With Different Surfaces
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Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
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Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
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All Edentulism trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01340170
Acronym / sponsor ID: YA-OTX-0002
Conditions: Edentulism
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
Study start: Apr 2011 (actual)
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 22 Apr 2011 (estimated)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Soft bone drilling protocol	Experimental	Device: OsseoSpeed TXA soft bone drilling protocol will be used in bone quality 3 and 4
Standard drilling protocol	Active comparator	Device: OsseoSpeed TXA standard drilling protocol will be used in bone quality 1 and 2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OsseoSpeed TXOsseoSpeed TX dental implants, 6-17 mm	Device	Soft bone drilling protocol, Standard drilling protocol

Primary outcome

Marginal Bone Level Change
Time frame: 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.

7 secondary outcomes

Marginal Bone Level Change
Time frame: Implant insertion and 3 months post implant insertion
Implant Survival Rate
Time frame: 12 months after baseline, i.e., implant insertion
Implant Stability Assessed Clinically/Manually
Time frame: At implant insertion
Implant Stability Using Resonance Frequency Analysis (RFA)
Time frame: At implant insertion.
Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"
Time frame: After implant insertion
Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"
Time frame: After implant insertion
Perception During Implant Insertion - "The Implant Has a Good Primary Stability"
Time frame: After implant insertion

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Drilling Protocol (Group A)	79	76
Soft Bone Drilling Protocol (Group B)	86	79
Group A + B	3	3

Primary outcome: Marginal Bone Level Change

Time frame: Implant insertion and 12 months post implant insertion. Mean (Standard Deviation). Unit: mm

Measure	Standard Drilling Protocol (Group A) n = 63	Soft Bone Drilling Protocol (Group B) n = 72
Value	-0.25 (0.9)	-0.2 (0.67)

Population analysed: ITT subjects with MBL data available (MBL data missing for 14 implants in Group A, and from 10 implants in group B). Outcome measure 1 is analyzed on implant level only and does not contain subject level group "Group A + B".

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment up to study termination, i.e., 1 year post implant insertion.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Drilling Protocol (Group A)	0 of 79 (0%)	0 of 79 (0%)	0 of 79
Soft Bone Drilling Protocol (Group B)	0 of 86 (0%)	0 of 86 (0%)	0 of 86
Group A + B	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Edentulism

Recruiting
Multi-Evaluation of Dental Abutments With Different Surfaces
Edentulism, Dental Implant
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Recruiting
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruggero Rodriguez y Baena, Prof principal investigator

University of Pavia

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OsseoSpeed TX in people with Edentulism, run by Dentsply Sirona Implants and Consumables at 9 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Marginal Bone Level Change (time frame: Implant insertion and 12 months post implant insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01340170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.