Mouth, EdentulousNCT01759537
Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.
A study testing Ankylos dental endosseous implants-Sub-crestal and Ankylos dental endosseous implants-Epi-crestal in people with Mouth, Edentulous, run by Dentsply International at 1 site in United States.
Trial summary
The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Ankylos dental endosseous implants-Sub-crestal and Ankylos dental endosseous implants-Epi-crestal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have read, understood and signed an informed consent form;
- Subjects must be 18 to 70 years of age;
- Subjects must be able and willing to follow study procedures and instructions;
- Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second);
- Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
- Sufficient vertical clearance to place a single tooth crown replacement;
- No apical disorder/inflammation at the area of the implant site.
Who cannot join
- Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
- Subjects with parafunctional habits;
- Subjects who have failed to maintain good plaque control;
- Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery;
- Absence of occlusal stability in centric occlusion;
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- Subjects with the presence of acute infectious lesions in the areas intended for surgery;
- History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day)
- Present alcohol or drug abuse;
- Angulation requirements of the restoration exceeding approximately 15 degrees;
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).
Trial locations and contacts
1 site in 1 country.
United States1 site
Bluestone Center for Clinical Research
New York, New York, 10010-4086
About this study
Official title: Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.
The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
Read the detailed description
The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
- Conditions
- Mouth, Edentulous
- Being tested
- Ankylos dental endosseous implants-Sub-crestal, Ankylos dental endosseous implants-Epi-crestal
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankylos dental endosseous implants-Sub-crestalDevice
Implants placed subcrestally
Ankylos dental endosseous implants-Epi-crestalDevice
Implants placed Epi-crestally
| Study group | Role | What they receive |
|---|---|---|
| Implants placed at sub-crestal position. | Experimental | Ankylos dental endosseous implants-Sub-crestal Receives: Device: Ankylos dental endosseous implants-Sub-crestal |
| Epi-crestal implants. | Active comparator | Ankylos dental endosseous implants-Epi-crestal Receives: Device: Ankylos dental endosseous implants-Epi-crestal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marginal Bone Level (MBL)
Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations.
Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.
Measured: Implant placement, and 18 months and 30 months after implant placement
Secondary outcomes (3)
Change in Mid-Buccal Soft Tissue Height
Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position.
Measured: From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Change of Interproximal Levels After Final Restoration
Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published "papilla Jemt index". Measurements will be assessed by reviewing the clinical photographs.
Reference: Jemt, T. (1997) "Regeneration of gingival papillae after single-implant treatment". International Journal of Periodontics and Restorative Dentistry 17: 326-333.
Measured: From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Change in Marginal Bone Level (MBL)
Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations.
Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66.
Measured: Implant placement, and 66 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2016
- Study completionApr 2019
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 Mouth, EdentulousStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a split mouth study design in which the same patient was used for both arms.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart J Froum, DDS, Principal investigator, Bluestone Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759537
- Sponsor's protocol ID
- Ankylos-Bluestone
- Status last verified
- Dec 2022
- First submitted
- 31 Dec 2012
- Last updated
- 29 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes of Hard and Soft Tissues After Epi-crestal and Sub-crestal Placement of Ankylos Dental Implants.
- ClinicalTrials.gov ID
- NCT01759537
- Acronym / sponsor ID
- Ankylos-Bluestone
- Conditions
- Mouth, Edentulous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 29 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
Detailed description
The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This was a split mouth study design in which the same patient was used for both arms.
| Arm | Type | Receives |
|---|---|---|
| Implants placed at sub-crestal position. | Experimental | Device: Ankylos dental endosseous implants-Sub-crestalAnkylos dental endosseous implants-Sub-crestal |
| Epi-crestal implants. | Active comparator | Device: Ankylos dental endosseous implants-Epi-crestalAnkylos dental endosseous implants-Epi-crestal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must have read, understood and signed an informed consent form;
- Subjects must be 18 to 70 years of age;
- Subjects must be able and willing to follow study procedures and instructions;
- Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second);
- Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant;
Key exclusion criteria (11 listed)
- Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing;
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study;
- Subjects with parafunctional habits;
- Subjects who have failed to maintain good plaque control;
- Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal 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 |
|---|---|---|
| Ankylos dental endosseous implants-Sub-crestalImplants placed subcrestally | Device | Implants placed at sub-crestal position. |
| Ankylos dental endosseous implants-Epi-crestalImplants placed Epi-crestally | Device | Epi-crestal implants. |
Primary outcome
Change in Marginal Bone Level (MBL)
Time frame: Implant placement, and 18 months and 30 months after implant placement
Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as "mid-facial bone levels". To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.
3 secondary outcomes
Change in Mid-Buccal Soft Tissue Height
Time frame: From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Change of Interproximal Levels After Final Restoration
Time frame: From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Change in Marginal Bone Level (MBL)
Time frame: Implant placement, and 66 months after implant placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Bluestone Clinic at NYULink provided by the sponsor.
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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.
Stuart J Froum, DDS principal investigator
Bluestone Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankylos dental endosseous implants-Sub-crestal and Ankylos dental endosseous implants-Epi-crestal in people with Mouth, Edentulous, run by Dentsply International at 1 site in United States.
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 11 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 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 29 Dec 2022). 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?
Change in Marginal Bone Level (MBL) (time frame: Implant placement, and 18 months and 30 months after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2022.