EdentulismNCT00807456
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
A study testing ASTRA TECH Implant System, OsseoSpeed™ in people with Edentulism, run by Dentsply Sirona Implants and Consumables at 5 sites in 3 countries.
Trial summary
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Edentulism
- What is being tested?
- ASTRA TECH Implant System, OsseoSpeed™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Nov 2008to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Aged 18-75 years at enrolment
- A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
- History of edentulism in the study area of at least 3 months
- Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.
- In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)
- Deemed by the investigator as likely to present an initially stable implant situation
Who cannot join
- 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
Show all 14Show fewer
- Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per day
- Present alcohol and/or drug abuse
- Current need for bone grafting in the planned implant area
- Previous enrolment in the present study
- Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months
- Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site)
- Unlikely to be able to comply with study procedures, as judged by the investigator
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Department of Periodontology, College of Dental Medicine, Nova Southeastern University
Fort Lauderdale, Florida, 33328-2018
Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Germany2 sites
Medizinische Hochschule Hannover
Hanover, D-30625
Praxis Dr Robert Nölken
Lindau, D-88131
About this study
Official title: A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.
The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
- Conditions
- Edentulism
- Being tested
- ASTRA TECH Implant System, OsseoSpeed™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTRA TECH Implant System, OsseoSpeed™Device
ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant | Experimental | Not described Receives: Device: ASTRA TECH Implant System, OsseoSpeed™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
Measured: At baseline and 16 weeks
Secondary outcomes (5)
Implant Survival Rate
The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.
Measured: 21 weeks, 12 months, 24 months and 36 months post implant placement.
Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis.
Measured: Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement
Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.
Measured: 21 weeks, 12 months, 24 months, and 36 months post implant placement
Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level.
Measured: Baseline and 12 months, 24 months, and 36 months post implant placement
Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level.
Measured: Baseline and 12 months, 24 months, and 36 months post implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tord Berglundh, Prof., Study chair, Department of Periodontology, Sahlgrenska Academy at University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807456
- Sponsor's protocol ID
- YA-PRO-0001
- Status last verified
- Nov 2022
- First submitted
- 11 Dec 2008
- Last updated
- 17 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5.
PubMed 23210667
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study
- ClinicalTrials.gov ID
- NCT00807456
- Acronym / sponsor ID
- YA-PRO-0001
- Conditions
- Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.
The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant | Experimental | Device: ASTRA TECH Implant System, OsseoSpeed™ |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent
- Aged 18-75 years at enrolment
- A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
- History of edentulism in the study area of at least 3 months
- Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| ASTRA TECH Implant System, OsseoSpeed™ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm. | Device | Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant |
Primary outcome
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
Time frame: At baseline and 16 weeks
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
5 secondary outcomes
Implant Survival Rate
Time frame: 21 weeks, 12 months, 24 months and 36 months post implant placement.
Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level
Time frame: Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement
Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)
Time frame: 21 weeks, 12 months, 24 months, and 36 months post implant placement
Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
Time frame: Baseline and 12 months, 24 months, and 36 months post implant placement
Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration
Time frame: Baseline and 12 months, 24 months, and 36 months post implant placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23210667Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5.
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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.
Tord Berglundh, Prof. study chair
Department of Periodontology, Sahlgrenska Academy at University of Gothenburg
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASTRA TECH Implant System, OsseoSpeed™ in people with Edentulism, run by Dentsply Sirona Implants and Consumables at 5 sites in 3 countries.
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 7 inclusion and 14 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 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, 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 30 May 2016). 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?
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement (time frame: At baseline and 16 weeks). 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 NCT00807456, which also lists 1 linked publication.
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 17 Nov 2022.