Alveolar Bone Loss
Conditions
Brief summary
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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 cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a solvent-based processing method (PUROS). 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 cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called 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 resorbable collagen membrane. Following 3 months 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
DEVICEPUROS (Ridge Preservation bone grafting surgery)
Ridge preservation bone grafting after tooth extraction
DEVICEFDBA (Ridge Preservation bone grafting surgery)
Ridge preservation bone grafting after tooth extraction
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 89 Years
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) | 3 months after ridge preservation | histologic determination of % of vital bone formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Residual Graft Material (Histological) | 3 months after ridge preservation | histologic determination of % of residual bone graft material |
Countries
United States
Participant flow
Pre-assignment details
After enrollment, one subject was withdrawn as a screen failure. This left a total of 43 subjects enrolled to take part in the study
Participants by arm
| Arm | Count |
|---|---|
| Non-Freeze-Dried Bone Allograft (PUROS) Ridge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
PUROS (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction | 21 |
| Freeze-Dried Bone Allograft (FDBA) Ridge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
FDBA (Ridge Preservation bone grafting surgery): Ridge preservation bone grafting after tooth extraction | 22 |
| Total | 43 |
Baseline characteristics
| Characteristic | Non-Freeze-Dried Bone Allograft (PUROS) | Freeze-Dried Bone Allograft (FDBA) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 1 / 21 | 0 / 22 |
Outcome results
Primary
% Vital Bone Formation (Histological)
histologic determination of % of vital bone formation
Time frame: 3 months after ridge preservation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Freeze-Dried Bone Allograft (PUROS) | % Vital Bone Formation (Histological) | 27.19 percentage | Standard Deviation 17.5 |
| Freeze-Dried Bone Allograft (FDBA) | % Vital Bone Formation (Histological) | 24.08 percentage | Standard Deviation 12.49 |
Secondary
% Residual Graft Material (Histological)
histologic determination of % of residual bone graft material
Time frame: 3 months after ridge preservation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Freeze-Dried Bone Allograft (PUROS) | % Residual Graft Material (Histological) | 23.38 percentage | Standard Deviation 13.45 |
| Freeze-Dried Bone Allograft (FDBA) | % Residual Graft Material (Histological) | 22.96 percentage | Standard Deviation 21.04 |