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

NCT03331185 | Completed Phase 2 Results FDA Drug

• 1 other identifier: B2017:125
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Loss; Tooth Loss

Keywords

Extraction; Alveolar Ridge Augmentation; Freeze Dried Bone Allograft; Leukocytic Platelet Rich Fibrin; Volumetric Changes; Dense Polytetrafluoroethylene Membrane

Outcome Measures

Primary Outcomes (1)

• Overall Horizontal Change in Alveolar Ridge Width

  Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.

  Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting

Secondary Outcomes (2)

• Buccolingual Change in Width of Keratinized Soft Tissue

  Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting

• Post-operative Pain and Swelling

  Measured at 7 days following extraction and grafting

Study Arms (2)

Freeze Dried Bone Allograft

ACTIVE COMPARATOR

Socket filled with Mineralized Cortical Freeze Dried Bone Allograft

Biological: Freeze Dried Bone Allograft

L-PRF Clot

EXPERIMENTAL

Socket filled with L-PRF Clot

Biological: L-PRF clot

Interventions

Freeze Dried Bone Allograft BIOLOGICAL

Human derived bone particles used in oral and periodontal grafting procedures

Also known as: FDBA

Freeze Dried Bone Allograft

L-PRF clot BIOLOGICAL

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.

Also known as: Leukocytic Platelet Rich Fibrin Clot

L-PRF Clot

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 presenting with the need for single extractions.
• Patients with general good health that does not have a condition contra-indicating routine dental treatment, extraction and implant placement.
• Patients that are compliant with the research protocol and methods.
• Patients that have read, understood and signed an informed consent form.

You may not qualify if:

• Extraction and ridge preservation indicated for teeth other than premolars and molars.
• Patients that present with a post extraction class III 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Graduate Periodontic Clinic - University of Manitoba

Winnipeg, Manitoba, R3E 0W2, Canada

Location

Related Publications (9)

• Temmerman A, Vandessel J, Castro A, Jacobs R, Teughels W, Pinto N, Quirynen M. The use of leucocyte and platelet-rich fibrin in socket management and ridge preservation: a split-mouth, randomized, controlled clinical trial. J Clin Periodontol. 2016 Nov;43(11):990-999. doi: 10.1111/jcpe.12612. Epub 2016 Sep 21.

  PMID: 27509214 BACKGROUND

• Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.

  PMID: 12931761 BACKGROUND

• Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27.

  PMID: 27788625 BACKGROUND

• Fernandez RF, Bucchi C, Navarro P, Beltran V, Borie E. Bone grafts utilized in dentistry: an analysis of patients' preferences. BMC Med Ethics. 2015 Oct 20;16(1):71. doi: 10.1186/s12910-015-0044-6.

  PMID: 26486125 BACKGROUND

• Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.

  PMID: 16504852 BACKGROUND

• Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.

  PMID: 23644909 BACKGROUND

• Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part B: sinus floor elevation, alveolar ridge preservation and implant therapy. A systematic review. J Clin Periodontol. 2017 Feb;44(2):225-234. doi: 10.1111/jcpe.12658. Epub 2017 Jan 10.

  PMID: 27891638 BACKGROUND

• MacBeth N, Trullenque-Eriksson A, Donos N, Mardas N. Hard and soft tissue changes following alveolar ridge preservation: a systematic review. Clin Oral Implants Res. 2017 Aug;28(8):982-1004. doi: 10.1111/clr.12911. Epub 2016 Jul 26.

  PMID: 27458031 BACKGROUND

• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

  PMID: 12956475 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss; Tooth Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Limitations and Caveats

Initial sample size calculation was 42, due to limited recruitment timeframe and period of study, a limited sample size was obtained.

Results Point of Contact

• Title: Dr. Jonathan Bouwer
• Organization: University of Manitoba

jfbouwer@gmail.com

204 898 1132

Study Officials

• Anastasia Cholakis, DDS

  University of Manitoba, Faculty of Graduate Studies, Periodontics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontal Resident

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 6, 2017
• Study Start: January 3, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)