Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

Not Applicable

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Device: Equimatrix®; Device: Bio-Oss®; Device: Endobon®

• Registration Number: NCT03149172
• Lead Sponsor: Tufts University

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.

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 Timeline

• Study Start: 2014-10-20
• Primary Completion: 2016-06-07
• Study Completion: 2016-12-07
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Results First Submitted: 2020-08-11
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Results First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Equimatrix®	Equimatrix®	Equimatrix® + Mucograft or alternatives
Bio-Oss®	Bio-Oss®	Bio-Oss® + Mucograft or alternatives
Endobon®	Endobon®	Endobon® + Mucograft or alternatives

Primary Outcome Measures

Name	Time	Method
Percent New Bone Formation	4-6 months after ridge preservation surgery	Histomorphometric determination of % new bone formation

Secondary Outcome Measures

Name	Time	Method
Bone Density	4-6 months after ridge preservation surgery	Measured by Micro CT Scanning

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States