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Changes of Soft and Hard Tissues After Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot
Phase 2, PHASE3 trial testing Freeze Dried Bone Allograft in Alveolar Bone Loss in 26 participants. Completed in 2 April 2019.
| Lead sponsor | University of Manitoba |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 3 January 2018 |
| Primary completion | 2 April 2019 |
| Estimated completion | 2 April 2019 |
| Sites | 1 location across Canada |
University of Manitoba
22 and older, any sex, with Alveolar Bone Loss or Tooth Loss. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.
| Group | Value | 95% CI |
|---|---|---|
| Freeze Dried Bone Allograft | -1.34 | ± 0.38 |
| L-PRF Clot | -2.21 | ± 0.41 |
Difference in post operative measurement analysis of keratinized gingiva changes following extraction and alveolar ridge preservation
| Group | Value | 95% CI |
|---|---|---|
| Freeze Dried Bone Allograft | -1 | ± 3.03 |
| L-PRF Clot | -4 | ± 2.7 |
Post-operative pain and complications measured by VAS-questionnaire obtained following extraction and grafting. The VAS-questionnaire contained the following categories to be answered 7days post-operatively: Pain, Swelling. A visual line scale of 100mm in length was provided with no pain/swelling on the one end and severe pain/swelling on the opposite end. Participants were instructed to rate their pain and swelling by marking a single line on the scale indicating the degree of pain/swelling they experienced. Markings were physically measured on the scale and converted into a score with 0 repr
| Group | Value | 95% CI |
|---|---|---|
| Freeze Dried Bone Allograft | 0.22 | ± 0.29 |
| L-PRF Clot | 0.23 | ± 0.30 |
Time frame: 12weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Freeze Dried Bone Allograft | L-PRF Clot |
|---|---|---|---|
| Membrane loss earlier than 4weeks | Surgical and medical procedures | — | — |
Data from ClinicalTrials.gov NCT03331185 adverse events section.
A Clinical Trial to study the effectiveness between two, tooth socket grafting materials namely, Freeze Dried Bone Allograft (human derived bone particles) and Leukocytic-Platelet Rich Fibrin (the patient's own centrifuged blood). The purpose of this study is to compare the effects (good and bad) of Bone Allograft to Platelet Rich Fibrin to see which material would be the most effective in maintaining the volume of the gum and bone of the jaw during the healing phase as well as minimizing the amount of pain and/or swelling following tooth extraction.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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