Changes of Soft and Hard Tissues After Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot
|ClinicalTrials.gov Identifier: NCT03331185|
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : April 30, 2020
Last Update Posted : April 30, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Bone Loss Tooth Loss||Biological: Freeze Dried Bone Allograft Biological: L-PRF clot||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A prospective,randomized clinical trial will be conducted. The trial aims at obtaining information to determine which material would provide a superior clinical result, as well as reporting on patient related outcomes. 42 participants will be randomly assigned to two groups and a direct comparison will be made between the results obtained from the two groups.|
|Masking:||None (Open Label)|
|Official Title:||Dimensional Changes of Soft and Hard Tissues Following Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot Covered With d-PTFE Membrane: A Randomized Clinical Trial|
|Actual Study Start Date :||January 3, 2018|
|Actual Primary Completion Date :||April 2, 2019|
|Actual Study Completion Date :||April 2, 2019|
Active Comparator: Freeze Dried Bone Allograft
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Biological: Freeze Dried Bone Allograft
Human derived bone particles used in oral and periodontal grafting procedures
Other Name: FDBA
Experimental: L-PRF Clot
Socket filled with L-PRF Clot
Biological: L-PRF clot
L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
Other Name: Leukocytic Platelet Rich Fibrin Clot
- Overall Horizontal Change in Alveolar Ridge Width [ Time Frame: Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting ]Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.
- Buccolingual Change in Width of Keratinized Soft Tissue [ Time Frame: Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting ]Difference in post operative measurement analysis of keratinized gingiva changes following extraction and alveolar ridge preservation
- Post-operative Pain and Swelling [ Time Frame: Measured at 7 days following extraction and grafting ]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 representing no pain/swelling and 1 representing severe pain/swelling.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331185
|Graduate Periodontic Clinic - University of Manitoba|
|Winnipeg, Manitoba, Canada, R3E 0W2|
|Study Director:||Anastasia Cholakis, DDS||University of Manitoba, Faculty of Graduate Studies, Periodontics|