Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

Alveolar Bone Loss Clinical Trial

Official title:

Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149172
• Other study ID #: #10963
• Status: Completed
• Phase: N/A
• Start date: October 20, 2014
• Est. completion date: December 7, 2016

Study information

• Verified date: September 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 7, 2016
• Est. primary completion date: June 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Device:
• Equimatrix®
Ridge preservation bone grafting after tooth extraction
• Bio-Oss®
Ridge preservation bone grafting after tooth extraction
• Endobon®
Ridge preservation bone grafting after tooth extraction

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent New Bone Formation	Histomorphometric determination of % new bone formation	4-6 months after ridge preservation surgery
Secondary	Bone Density	Measured by Micro CT Scanning	4-6 months after ridge preservation surgery