Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

NCT03149172 | Completed Results FDA Device

• 1 other identifier: #10963
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Percent New Bone Formation

  Histomorphometric determination of % new bone formation

  4-6 months after ridge preservation surgery

Secondary Outcomes (1)

• Bone Density

  4-6 months after ridge preservation surgery

Study Arms (3)

Equimatrix®

EXPERIMENTAL

Equimatrix® + Mucograft or alternatives

Device: Equimatrix®

Bio-Oss®

EXPERIMENTAL

Bio-Oss® + Mucograft or alternatives

Device: Bio-Oss®

Endobon®

EXPERIMENTAL

Endobon® + Mucograft or alternatives

Device: Endobon®

Interventions

Equimatrix® DEVICE

Ridge preservation bone grafting after tooth extraction

Equimatrix®

Bio-Oss® DEVICE

Ridge preservation bone grafting after tooth extraction

Bio-Oss®

Endobon® DEVICE

Ridge preservation bone grafting after tooth extraction

Endobon®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Yong Hur
• Organization: Tufts University

Yong.Hur@tufts.edu

6176366531

Study Officials

• Yong Hur, DDS, DMD, MS

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The surgeon and the subject will not be blinded. The evaluation of the core histology will be done by a blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: October 20, 2014
• Primary Completion: June 7, 2016
• Study Completion: December 7, 2016
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)