Alveolar Bone Loss
Conditions
Brief summary
The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Detailed description
The study is designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The study is a 3-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Interventions
DEVICE50% cortical/50% cancellous FDBA
Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
DEVICE100% cortical FDBA
Ridge preservation after tooth extraction using 100% cortical FDBA
DEVICE100% cancellous FDBA
Ridge preservation after tooth extraction using 100% cancellous FDBA
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients will be included in this study if they qualify the following inclusion criteria: * Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio * Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol * A single rooted tooth that has been identified as requiring extraction * Desire a dental implant 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 only be included if they smoke \<10 cigarettes per day
Exclusion criteria
* Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio * Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule. * Patients will are mentally incompetent, prisoners, or pregnant. * Pregnant women or women intending to become pregnant during the study period. * 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. * Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Vital Bone Formation (Histological) | 18-20 weeks after ridge preservation | histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Residual Graft Material (Histological) | 18-20 weeks after ridge preservation | histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combination 50% Cortical/50% Cancellous FDBA Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)
50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA | 22 |
| 100% Cortical FDBA Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA | 22 |
| 100% Cancellous FDBA Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)
100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA | 22 |
| Total | 66 |
Baseline characteristics
| Characteristic | Combination 50% Cortical/50% Cancellous FDBA | 100% Cortical FDBA | 100% Cancellous FDBA | Total |
|---|---|---|---|---|
| Age, Continuous | 54.4 years | 52.6 years | 53.7 years | 53.2 years |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 10 Participants | 37 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
% Vital Bone Formation (Histological)
histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery
Time frame: 18-20 weeks after ridge preservation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination 50% Cortical/50% Cancellous FDBA | % Vital Bone Formation (Histological) | 26.4 percentage of total area | Standard Deviation 13.2 |
| 100% Cortical FDBA | % Vital Bone Formation (Histological) | 24.5 percentage of total area | Standard Deviation 8.6 |
| 100% Cancellous FDBA | % Vital Bone Formation (Histological) | 28.8 percentage of total area | Standard Deviation 14.1 |
Secondary
% Residual Graft Material (Histological)
histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery
Time frame: 18-20 weeks after ridge preservation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination 50% Cortical/50% Cancellous FDBA | % Residual Graft Material (Histological) | 23.4 percentage of total area | Standard Deviation 12.5 |
| 100% Cortical FDBA | % Residual Graft Material (Histological) | 28.1 percentage of total area | Standard Deviation 10.7 |
| 100% Cancellous FDBA | % Residual Graft Material (Histological) | 18.8 percentage of total area | Standard Deviation 8.4 |