Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets.

Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Device: Equimatrix®; Device: Bio-Oss®; Device: Endobon®

Detailed Description

This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®.

Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®.

The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.

Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®.

The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-restorable single rooted tooth in anterior or premolar region
• Patient previously treatment planned for implant procedure and implant restoration.
• > 10 mm from maxillary sinus or inferior alveolar canal (IAC)
• Intact buccal bone (only minor dehiscence or fenestrations (approximately < 50% of socket depth) can be accepted
• Non-smokers.
• Patients treatment planned for extraction and ridge preservation at Tufts University School of Dental Medicine.

Exclusion Criteria:

• Poor oral hygiene (plaque index>30%).

• Systemic diseases that affect bone metabolism:

  i. Osteoporosis ii. Osteomalacia iii. Hyperthyroidism iv. Hyperparathyroidism v. Paget's disease

• Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):

  i. Severe chronic periodontitis ii. Aggressive periodontitis iii. Necrotizing ulcerative periodontitis iv. Crohn's disease v. Multiple sclerosis vi. Rheumatoid arthritis vii. Systemic lupus erythematosus

• History of radiation to the head and neck, and /or chemotherapy.
• Current corticosteroid therapy.
• History of IV Bisphosphonates therapy or >3 years of oral intake.
• Infectious diseases such as HIV, tuberculosis, Hepatitis (self-report).
• Known allergy to research related materials.
• Self-reported pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Equimatrix®; Equimatrix® + Mucograft or alternatives	Device: Equimatrix®; Ridge preservation bone grafting after tooth extraction
EXPERIMENTAL: Bio-Oss®; Bio-Oss® + Mucograft or alternatives	Device: Bio-Oss®; Ridge preservation bone grafting after tooth extraction
EXPERIMENTAL: Endobon®; Endobon® + Mucograft or alternatives	Device: Endobon®; Ridge preservation bone grafting after tooth extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent New Bone Formation	Histomorphometric determination of % new bone formation	4-6 months after ridge preservation surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Density	Measured by Micro CT Scanning	4-6 months after ridge preservation surgery

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Yong Hur, DDS, DMD, MS, Tufts University School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2014
• Primary Completion (ACTUAL): June 7, 2016
• Study Completion (ACTUAL): December 7, 2016

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: #10963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes