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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03149172
Other study ID # #10963
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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