Tooth LossNCT02174198
Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting
A study testing BioOss Collagen at the time of implant placement in people with Tooth Loss, run by Columbia University at 1 site in United States.
Trial summary
This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- BioOss Collagen at the time of implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have read, understood and signed an informed consent form.
- Subjects must be willing and able to follow study procedures and instructions.
- Subjects must have labial plate of bone present after extraction no more than 4 mm from the free gingival margin.
- Subjects must require one maxillary anterior implant.
- Subjects must be older than 18 years
Who cannot join
- Subjects having participated within the last six months in other clinical studies.
- Subjects who have failed to maintain good plaque control.
- Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, human immunodeficiency virus (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.
- Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- History within the last 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day).
- Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
Show all 11Show fewer
- Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values <100
- Subjects requiring antibiotic prophylaxis for subacute bacterial endocarditis (SBE) or late prosthetic joint infection. Patients who cannot undergo standard oral surgery procedure for any reason.
- Subjects that have adjacent teeth next to tooth slated for extraction and immediate placement showing periodontal disease, endodontic and/or caries pathology will be excluded.
- Subjects having unfavorable occlusal schemes for immediate loading, parafunctional habits and inadequate posterior support to properly protect the anterior teeth during function.
- Implant site will not be next to an adjacent implant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University, College of Dental Medicine
New York, New York, 10032
About this study
Official title: The Esthetic Effect of Bio-OSS Collagen® on the Mid-facial Gingival Dimensions When Placed Into Gaps Between 3i® Implants Placed Into Fresh Extraction Sockets and the Labial Plate of Bone
This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown.
The investigators will be researching and comparing the changes in gum level that occur after each surgical method, as well as changes in jaw width where the implant is placed.
The investigators will enroll 16 patients per group. The patients will be followed for 3, 6, and 12 months post-immediate implant placement to observe healing.
Read the detailed description
The purpose of the current study is to evaluate the soft tissue dimensional changes after extraction of teeth in the esthetic zone, when combined with the placement of implants into these fresh extraction sockets. In addition, the effect of placing a graft material, such as Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated after an immediately loaded provisional restoration is placed. 32 subjects will have an immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test group) and 16 subjects will have no graft (Control group) in the gap between the implant and the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants will be placed in a flapless procedure. Implants will be immediately loaded with provisional restorations once determined that the implant is stable. Changes in vertical height and horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12 months post-immediate implant placement.
- Conditions
- Tooth Loss
- Being tested
- BioOss Collagen at the time of implant placement
- Keywords
- Immediate implant, bone graft, immediate restoration
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioOss Collagen at the time of implant placementDevice
Also called BioOss Collagen, Geistlich Pharma Inc.
Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
| Study group | Role | What they receive |
|---|---|---|
| BioOss Collagen | Experimental | Intervention: BioOss Collagen at the time of implant placement Receives: Device: BioOss Collagen at the time of implant placement |
| No Bone Graft | No intervention | No placement of BioOss at the time of implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Bucco-Lingual Change at 3mm
The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.
Measured: Baseline and 12 months
Mean Bucco-Lingual Change at 4mm
The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.
Measured: Baseline and 12 months
Secondary outcomes (7)
Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)
The mean change was calculated from a tooth-supported stent to the free gingival margin.
Measured: Baseline and 12 months
Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)
The mean change was calculated from a tooth-supported stent to the free gingival margin.
Measured: Baseline and 12 months
Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)
The mean change was calculated from a tooth-supported stent to the free gingival margin.
Measured: Baseline and 12 months
Periodontal Probing Depth
The periodontal probing depth will be measured in mm.
Measured: 12 months
Thickness of Keratinized Tissue at 3mm
Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Measured: 12 months
Thickness of Keratinized Tissue at 4mm
Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Measured: 12 months
Thickness of Keratinized Tissue at 8mm
Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2018
- Study completionAug 2018
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 Tooth LossStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Nurit Bittner Fogel, Columbia University
- Investigators
- Nurit Bittner Fogel, DDS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174198
- Sponsor's protocol ID
- AAAM4053
- Status last verified
- May 2019
- First submitted
- 23 Jun 2014
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Esthetic Effect of Bio-OSS Collagen® on the Mid-facial Gingival Dimensions When Placed Into Gaps Between 3i® Implants Placed Into Fresh Extraction Sockets and the Labial Plate of Bone
- ClinicalTrials.gov ID
- NCT02174198
- Acronym / sponsor ID
- AAAM4053
- Conditions
- Tooth Loss
- Keywords
- Immediate implant, bone graft, immediate restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown.
The investigators will be researching and comparing the changes in gum level that occur after each surgical method, as well as changes in jaw width where the implant is placed.
The investigators will enroll 16 patients per group. The patients will be followed for 3, 6, and 12 months post-immediate implant placement to observe healing.
Detailed description
The purpose of the current study is to evaluate the soft tissue dimensional changes after extraction of teeth in the esthetic zone, when combined with the placement of implants into these fresh extraction sockets. In addition, the effect of placing a graft material, such as Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated after an immediately loaded provisional restoration is placed. 32 subjects will have an immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test group) and 16 subjects will have no graft (Control group) in the gap between the implant and the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants will be placed in a flapless procedure. Implants will be immediately loaded with provisional restorations once determined that the implant is stable. Changes in vertical height and horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12 months post-immediate implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioOss Collagen | Experimental | Device: BioOss Collagen at the time of implant placementIntervention: BioOss Collagen at the time of implant placement |
| No Bone Graft | No intervention | –No placement of BioOss at the time of implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must have read, understood and signed an informed consent form.
- Subjects must be willing and able to follow study procedures and instructions.
- Subjects must have labial plate of bone present after extraction no more than 4 mm from the free gingival margin.
- Subjects must require one maxillary anterior implant.
- Subjects must be older than 18 years
Key exclusion criteria (11 listed)
- Subjects having participated within the last six months in other clinical studies.
- Subjects who have failed to maintain good plaque control.
- Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, human immunodeficiency virus (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.
- Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- History within the last 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day).
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 |
|---|---|---|
| BioOss Collagen at the time of implant placementAlso: BioOss Collagen, Geistlich Pharma Inc.Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen | Device | BioOss Collagen |
Primary outcome
Mean Bucco-Lingual Change at 3mm
Time frame: Baseline and 12 months
The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.
Mean Bucco-Lingual Change at 4mm
Time frame: Baseline and 12 months
The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.
7 secondary outcomes
Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)
Time frame: Baseline and 12 months
Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)
Time frame: Baseline and 12 months
Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)
Time frame: Baseline and 12 months
Periodontal Probing Depth
Time frame: 12 months
Thickness of Keratinized Tissue at 3mm
Time frame: 12 months
Thickness of Keratinized Tissue at 4mm
Time frame: 12 months
Thickness of Keratinized Tissue at 8mm
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nurit Bittner Fogel, DDS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioOss Collagen at the time of implant placement in people with Tooth Loss, run by Columbia University 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 5 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 13 Jun 2019. 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 13 Jun 2019). 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?
Mean Bucco-Lingual Change at 3mm (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. 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 13 Jun 2019.