Tooth LossPhase 4NCT00782236
Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets
A Phase 4 study testing Bone Graft Material in people with Tooth Loss, run by Institut Straumann AG at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Bone Graft Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have voluntarily signed the informed consent form
- Subjects must be between the ages of 18 and 80
- Subjects must need a single tooth extraction in ADA sites 3-6 and 11-14 without septal bone in the maxilla and in ADA sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant
- Subjects must be committed to the study and the required follow-up visits
- Subjects must be in good general health as assessed by the Investigator
Who cannot join
- Presence of conditions requiring chronic routine prophylactic use of antibiotics
- Pregnancy
- Medical conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- History of bleeding disorders
- History of neoplastic disease requiring the use of chemotherapy
Show all 27Show fewer
- History of radiation therapy to the head and neck
- Subjects with a history of renal failure
- Subjects with severe or uncontrolled metabolic bone disorders
- Uncontrolled endocrine disorders
- Subjects who knowingly have HIV or hepatitis
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study
- Alcoholism or drug abuse
- Subjects who are heavy smokers (>10 cigarettes per day or cigar equivalents) or chew tobacco
- Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- Local inflammation including untreated periodontitis
- Mucosal diseases such as erosive lichen planus
- History of local radiation therapy
- Presence of oral lesions (such as ulcerations or malignancy)
- Bone defects that exclude implant restoration
- Subjects who have a full mouth plaque level >30% at the baseline visit
- Severe bruxing or clenching habits
- Persistent intra-oral infection
- Subjects presenting with an acute abscess in the tooth to be extracted or in the adjacent teeth to the extraction site (sites with presence of asymptomatic chronic lesions are eligible)
- Subjects with inadequate oral hygiene or unmotivated for adequate home care
- At the time of tooth extraction, if any bony wall is severely damaged or completely lost (i.e., anything other than a four wall extraction socket)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of an Alloplast (Straumann Bone Ceramic) to an Allograft of Freeze Dried Bone (FDBA) for Preservation of the Alveolar Ridge Following Tooth Extraction: a Prospective, Randomized, Controlled Clinical Study
The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).
Read the detailed description
Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.
- Conditions
- Tooth Loss
- Being tested
- Bone Graft Material
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Graft MaterialDevice
Also called Synthetic bone substitute, Allograft bone
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Straumann BoneCeramic | Active comparator | In the test group, the subjects will receive the Bone Graft Material Straumann BoneCeramic in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction. Receives: Device: Bone Graft Material |
| Freeze Dried Allograft Bone | Active comparator | In the control group, the subjects will receive Bone Graft Material Freeze Dried Allograft Bone in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction. Receives: Device: Bone Graft Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.
Measured: Six weeks following dental implant placement
Secondary outcomes (7)
Histological evaluation
Measured: 6 months following tooth extraction
Alveolar ridge width and height changes
Measured: 6 months following tooth extraction
Periodontal measurements
Measured: 6 months following tooth extraction and 6 and 12 months following implant placement
Grafting procedure success rate
Measured: 14 days, 1 month, 3 months, and 6 months following tooth extraction
Implant success and survival rate
Measured: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Mesial and distal implant bone level changes
Measured: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Patient satisfaction
Measured: 6 and 12 months following implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJun 2006
- Primary completionNov 2007
- Study completionOct 2009
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul S. Rosen, DMD, MS, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782236
- Sponsor's protocol ID
- CR 02/06
- Status last verified
- Mar 2016
- First submitted
- 28 Oct 2008
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Alloplast (Straumann Bone Ceramic) to an Allograft of Freeze Dried Bone (FDBA) for Preservation of the Alveolar Ridge Following Tooth Extraction: a Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT00782236
- Acronym / sponsor ID
- CR 02/06
- Conditions
- Tooth Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).
Detailed description
Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straumann BoneCeramic | Active comparator | Device: Bone Graft MaterialIn the test group, the subjects will receive the Bone Graft Material Straumann BoneCeramic in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction. |
| Freeze Dried Allograft Bone | Active comparator | Device: Bone Graft MaterialIn the control group, the subjects will receive Bone Graft Material Freeze Dried Allograft Bone in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have voluntarily signed the informed consent form
- Subjects must be between the ages of 18 and 80
- Subjects must need a single tooth extraction in ADA sites 3-6 and 11-14 without septal bone in the maxilla and in ADA sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant
- Subjects must be committed to the study and the required follow-up visits
- Subjects must be in good general health as assessed by the Investigator
Key exclusion criteria (27 listed)
- Presence of conditions requiring chronic routine prophylactic use of antibiotics
- Pregnancy
- Medical conditions requiring prolonged use of steroids
- History of leukocyte dysfunction and deficiencies
- History of bleeding disorders
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 |
|---|---|---|
| Bone Graft MaterialAlso: Synthetic bone substitute, Allograft boneAfter screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement. | Device | Freeze Dried Allograft Bone, Straumann BoneCeramic |
Primary outcome
Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.
Time frame: Six weeks following dental implant placement
7 secondary outcomes
Histological evaluation
Time frame: 6 months following tooth extraction
Alveolar ridge width and height changes
Time frame: 6 months following tooth extraction
Periodontal measurements
Time frame: 6 months following tooth extraction and 6 and 12 months following implant placement
Grafting procedure success rate
Time frame: 14 days, 1 month, 3 months, and 6 months following tooth extraction
Implant success and survival rate
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Mesial and distal implant bone level changes
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Patient satisfaction
Time frame: 6 and 12 months following implant placement
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- 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.
Paul S. Rosen, DMD, MS principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bone Graft Material in people with Tooth Loss, run by Institut Straumann AG 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 27 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: stopped early, as of the sponsor's last update on 4 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved. (time frame: Six weeks following dental 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 4 Mar 2016.