Dental Extraction, Wound Heal
Conditions
Keywords
Ridge preservation, Implant
Brief summary
The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and connective tissue/other 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.
Detailed description
The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % CT/other (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.
Interventions
DEVICEVallos (DCP)
Demineralized freeze-dried bone allograft (DFBA) in a small particle form
DEVICEVallomix (DCF)
A combination of cow-derived xenograft and human-derived DFDBA particulate
DEVICEVallos-F (DPX)
Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
DEVICEVallomix-F (DFX)
A combination of cow-derived xenograft and human-derived DFDBA fibers
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Since the outcome of the study is the histologic healing, blinding of the surgeon is not necessary. Blinding is performed only for histomorphometric measurements. The person doing histomorphometric analysis is blinded as to study group.
Intervention model description
4 arm randomized controlled parallel study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 |
|---|---|---|
| Percentage Vital Bone Formation | Wound healing time ( approximately 18 to 20 weeks) | Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Residual Graft Material | Wound healing time ( approximately 18 to 20 weeks) | Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery. |
| Percentage of Connective Tissue at Time of Implant | Baseline to 18-20 weeks | Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery. |
| Change in Ridge Width (Clinical Measurement) | Baseline to 18-20 weeks | Measure of change in ridge width from extraction to healing time |
| Change in Buccal Ridge Height (Clinical Measurement) | Baseline to 18-20 weeks | Measure of change in buccal ridge height from extraction to healing time |
| Change in Lingual Ridge Height (Clinical Measurement) | Baseline to 18-20 weeks | Measure of change in lingual ridge height from extraction to healing time |
Countries
United States
Participant flow
Recruitment details
All patients presented with one non-molar tooth that was indicated for extraction and planned for an implant restoration. Additional inclusion criteria included the following: 1) adequate restorative space for an implant restoration, 2) at least 10mm of alveolar ridge height before any vital structures, and 3) non-smokers or current smokers smoking \<10 cigarettes per day.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Vallos (DCP) Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form | 24 |
| Group 2 Vallomix (DPX) Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate | 27 |
| Group 3 Vallos-F (DCF) Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form | 24 |
| Group 4 Vallomix-F (DFX) Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers | 27 |
| Total | 102 |
Baseline characteristics
| Characteristic | Group 2 Vallomix (DPX) | Group 3 Vallos-F (DCF) | Group 4 Vallomix-F (DFX) | Total | Group 1 Vallos (DCP) |
|---|---|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 16.8 | 55.9 years STANDARD_DEVIATION 15.4 | 63.2 years STANDARD_DEVIATION 9.6 | 60.17 years STANDARD_DEVIATION 14.98 | 61.9 years STANDARD_DEVIATION 16.9 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 27 participants | 24 participants | 27 participants | 102 participants | 24 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 10 Participants | 43 Participants | 15 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 17 Participants | 59 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 0 / 24 | 0 / 27 | 0 / 24 | 0 / 27 |
| serious Total, serious adverse events | 0 / 24 | 1 / 27 | 0 / 24 | 0 / 27 |
Outcome results
Primary
Percentage Vital Bone Formation
Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery.
Time frame: Wound healing time ( approximately 18 to 20 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Vallos (DCP) | Percentage Vital Bone Formation | 37.33 percentage of vital bone formation | Standard Deviation 14.31 |
| Group 2 Vallos-F (DPX) | Percentage Vital Bone Formation | 40.76 percentage of vital bone formation | Standard Deviation 13.94 |
| Group 3 Vallomix (DCF) | Percentage Vital Bone Formation | 24.46 percentage of vital bone formation | Standard Deviation 13.75 |
| Group 4 Vallomix-F | Percentage Vital Bone Formation | 23.85 percentage of vital bone formation | Standard Deviation 17.71 |
Secondary
Change in Buccal Ridge Height (Clinical Measurement)
Measure of change in buccal ridge height from extraction to healing time
Time frame: Baseline to 18-20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Vallos (DCP) | Change in Buccal Ridge Height (Clinical Measurement) | -1.67 mm | Standard Deviation 1.99 |
| Group 2 Vallos-F (DPX) | Change in Buccal Ridge Height (Clinical Measurement) | -0.85 mm | Standard Deviation 1.33 |
| Group 3 Vallomix (DCF) | Change in Buccal Ridge Height (Clinical Measurement) | -0.41 mm | Standard Deviation 2.19 |
| Group 4 Vallomix-F | Change in Buccal Ridge Height (Clinical Measurement) | -1.08 mm | Standard Deviation 1.37 |
Secondary
Change in Lingual Ridge Height (Clinical Measurement)
Measure of change in lingual ridge height from extraction to healing time
Time frame: Baseline to 18-20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Vallos (DCP) | Change in Lingual Ridge Height (Clinical Measurement) | -1.85 mm | Standard Deviation 1.63 |
| Group 2 Vallos-F (DPX) | Change in Lingual Ridge Height (Clinical Measurement) | -0.75 mm | Standard Deviation 1.76 |
| Group 3 Vallomix (DCF) | Change in Lingual Ridge Height (Clinical Measurement) | -1.17 mm | Standard Deviation 1.72 |
| Group 4 Vallomix-F | Change in Lingual Ridge Height (Clinical Measurement) | -1.75 mm | Standard Deviation 1.8 |
Secondary
Change in Ridge Width (Clinical Measurement)
Measure of change in ridge width from extraction to healing time
Time frame: Baseline to 18-20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Vallos (DCP) | Change in Ridge Width (Clinical Measurement) | -1.19 mm | Standard Deviation 0.94 |
| Group 2 Vallos-F (DPX) | Change in Ridge Width (Clinical Measurement) | -1.02 mm | Standard Deviation 1.57 |
| Group 3 Vallomix (DCF) | Change in Ridge Width (Clinical Measurement) | -1.15 mm | Standard Deviation 1.02 |
| Group 4 Vallomix-F | Change in Ridge Width (Clinical Measurement) | -1.00 mm | Standard Deviation 1.66 |
Secondary
Percentage of Connective Tissue at Time of Implant
Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery.
Time frame: Baseline to 18-20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Vallos (DCP) | Percentage of Connective Tissue at Time of Implant | 46.41 percentage of connective tissue | Standard Deviation 14.23 |
| Group 2 Vallos-F (DPX) | Percentage of Connective Tissue at Time of Implant | 55.67 percentage of connective tissue | Standard Deviation 14.28 |
| Group 3 Vallomix (DCF) | Percentage of Connective Tissue at Time of Implant | 52.03 percentage of connective tissue | Standard Deviation 12.1 |
| Group 4 Vallomix-F | Percentage of Connective Tissue at Time of Implant | 57.73 percentage of connective tissue | Standard Deviation 14.72 |
Secondary
Percentage of Residual Graft Material
Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery.
Time frame: Wound healing time ( approximately 18 to 20 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Vallos (DCP) | Percentage of Residual Graft Material | 16.25 percentage of residual graft material | Standard Deviation 13.84 |
| Group 2 Vallos-F (DPX) | Percentage of Residual Graft Material | 3.57 percentage of residual graft material | Standard Deviation 2.78 |
| Group 3 Vallomix (DCF) | Percentage of Residual Graft Material | 23.39 percentage of residual graft material | Standard Deviation 8.95 |
| Group 4 Vallomix-F | Percentage of Residual Graft Material | 18.42 percentage of residual graft material | Standard Deviation 10.24 |