TEETH EXTRACTION
Conditions
Brief summary
This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched. Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement. The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.
Interventions
DEVICEOssix™ Bone
a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
DEVICEBio-Oss® Collagen
90% bovine derived xenograft granules and 10% porcine collagen
Sponsors
Datum Dental LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction * A dental implant is indicated and treatment planned to replace the missing tooth * Have adequate restorative space for a dental implant-retained restoration * Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal. * Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket. * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential. * Are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day
Exclusion criteria
* Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant. * Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected). * Patients who become pregnant during the study will be withdrawn and standard care will be delivered. * Smokers who smoke \>10 cigarettes per day * Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Vital Bone Formation, | 16 weeks | shows the amount of new bone formed after the procedure |
| Percent Residual Graft Material | 16 weeks | shows how much of the graft material remained intact |
| Percent Fibrous Tissue and Marrow Space | 16 weeks | amount of tissue that is neither native bone or graft material |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BioOss Collagen no adverse events were observed | 27 |
| Ossix™ Bone no adverse events were observed | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Ossix™ Bone | Total | BioOss Collagen |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 54 Participants | 27 Participants |
| Age, Continuous | 55 YEARS | 55 YEARS | 55 YEARS |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 27 participants | 54 participants | 27 participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 21 |
| other Total, other adverse events | 0 / 23 | 0 / 21 |
| serious Total, serious adverse events | 0 / 23 | 0 / 21 |
Outcome results
Primary
Percent Fibrous Tissue and Marrow Space
amount of tissue that is neither native bone or graft material
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bio-Oss® Collagen, | Percent Fibrous Tissue and Marrow Space | 55.2 percentage of marrow | Standard Deviation 12.7 |
| Ossix™ Bone | Percent Fibrous Tissue and Marrow Space | 60.7 percentage of marrow | Standard Deviation 17.8 |
Primary
Percent Residual Graft Material
shows how much of the graft material remained intact
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bio-Oss® Collagen, | Percent Residual Graft Material | 17.9 percentage of residual graft | Standard Deviation 13.6 |
| Ossix™ Bone | Percent Residual Graft Material | 0 percentage of residual graft | Standard Deviation 0 |
Primary
Percent Vital Bone Formation,
shows the amount of new bone formed after the procedure
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bio-Oss® Collagen, | Percent Vital Bone Formation, | 26.8 percentage of vital bone | Standard Deviation 15.8 |
| Ossix™ Bone | Percent Vital Bone Formation, | 39.3 percentage of vital bone | Standard Deviation 17.8 |