Phase 3
N=26
Changes of Soft and Hard Tissues After Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot
Alveolar Bone Loss · Tooth Loss
Bottom Line
View on ClinicalTrials.gov: NCT03331185 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Overall Horizontal Change in Alveolar Ridge Width — -1.34; -2.21 Millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Freeze Dried Bone Allograft (Biological); L-PRF clot (Biological)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of Manitoba
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Horizontal Change in Alveolar Ridge Width |
-1.34; -2.21 | — |
| SECONDARY Buccolingual Change in Width of Keratinized Soft Tissue |
-1; -4 | — |
| SECONDARY Post-operative Pain and Swelling |
0.22; 0.23 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects with molars or premolars indicated for extraction.
- Patients that present with a post extraction class I and II socket ( 30% bone loss on the buccal or lingual plate, measured from the most coronal aspect of intact bone to the most apical aspect of the defect divided by the measurement from the most apical aspect of the defect to the apex of the socket x 100)
- Patients deemed eligible for immediate implant placement following extraction and intra-operative assessment by the attending supervisor.
- Patients that present with an oral-antral communication, post extraction.
- Patients that presents with the need for multiple, side by side extractions.
- Patients with coagulation disorders, on corticosteroids, uncontrolled diabetes mellitus, or any systemic disease where periodontal surgery is contraindicated and healing may be compromised.
- Pregnant and nursing women.
- Patients with any contact hypersensitivity to the related materials used in the study.
- Heavy tobacco users, >10 cigarettes per day.
- Patients unwilling to sign consent or follow the protocol of the study.
Data sourced from ClinicalTrials.gov (NCT03331185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.