NCT03331185

Changes of Soft and Hard Tissues After Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Detailed description

A prospective,randomized clinical trial will be conducted to determine whether L-PRF, compared to freeze dried bone allograft, will result in comparable volumetric shrinkage of the alveolar ridge and overlying keratinized tissue, following extraction of teeth and socket grafting. This trial aims at obtaining information to determine which material would provide a superior clinical result, as well as reporting on patient related outcomes. The participants will be randomly assigned to two groups. The surgical procedure will be performed by one of five calibrated periodontal residents. Patients will be followed for 2 weeks post-operatively by the same resident, to monitor the healing process and to assess for any complications. Randomization will be achieved using a computerized randomization scheme and will be assigned to one of two groups and allocated by means of a sealed envelope opened on the day of surgery communicated to the surgeon during the surgery by a supervising faculty member. Participants will be block-randomized for each of the 5 operators for balance. Anesthesia will be achieved and soft tissue measurements will be obtained using a periodontal probe. An atraumatic extraction technique will be performed to allow for minimal disturbance of the soft and hard tissue architecture. The extraction socket walls are then assessed and any defects in socket measured with a periodontal probe. Group A: Full thickness mucoperiosteal pouch is created up to \~3mm apical of the bony crest of the socket with a periosteal elevator. The socket is incrementally filled with mineralized cortical freeze-dried bone allograft and condensed. Group B: Socket is pouched as in group A followed by venipuncture of the antecubital vein with 21G needle and collection of 4-6 vials (10ml each) of venous blood without any additive or anticoagulant. The vials are centrifuged for 12 minutes at 2700 rpm to form L-PRF clots. The socket is incrementally filled with the clots and condensed. Following socket fill, both groups will have the grafts covered by dense polytetrafluoroethylene membrane. The membrane is trimmed and adapted with the borders tucked 2-3mm underneath the gingival tissues. Tissues, graft and membrane are stabilized with 5/0 PTFE sutures. The patients will also receive a pain VAS questionnaire evaluating the post-operative pain 1 and 7 days following surgery. A CBCT with the radiographic stent will be taken within 72 hours of the surgery. 7 days post-op: Sutures will be removed if deemed suitable. The VAS questionnaire will be collected. 6 weeks post op: d-PTFE membrane will be retrieved and discarded using tissue forceps. Alginate impressions will be taken for a surgical guide. 11 weeks post op: Second CBCT will be taken with radiographic surgical stent. Images obtained will be used to analyze and compare the ridge dimensions to those obtained at baseline as well as for surgical implant planning. 12 weeks post op: Soft tissue measurement with periodontal probe and floss spanned over edentulous site from buccal to lingual mucogingival junction. Implant placement will be done per standard procedure. A 2.5mm diameter trephine drill will be used to harvest a bone core for histologic analysis. The bone core will be immediately submerged in a solution of 10% neutral buffered formalin. Osteotomies and implant placement will be done following the manufacturer's protocol. Depending on the buccal bone and soft tissue thickness, ancillary soft tissue augmentation, bone augmentation or combination of these procedures may be indicated. The patient will be followed up and referred to the restorative dentist as per standard procedure. Photographs will be taken at every visit.

Conditions

• Alveolar Bone Loss
• Tooth Loss

Interventions

Type	Name	Description
BIOLOGICAL	Freeze Dried Bone Allograft	Human derived bone particles used in oral and periodontal grafting procedures
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.

Timeline

• Start date: 2018-01-03
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2017-11-06
• Last updated: 2020-04-30
• Results posted: 2020-04-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study