Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05470673 - Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation N/A
Recruiting NCT02580721 - The Influence of Mucosal Tissue Thickness on Soft and Hard Tissue Changes Around Implants N/A
Completed NCT02515058 - Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts N/A
Enrolling by invitation NCT02209311 - Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs Phase 1/Phase 2
Completed NCT02602223 - Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures Phase 2
Completed NCT02255149 - A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw N/A
Recruiting NCT05674331 - Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation N/A
Recruiting NCT06081296 - Dimensional Changes in Alveolar Ridge Preservation N/A
Completed NCT03944811 - Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique N/A
Completed NCT03045458 - Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures N/A
Completed NCT05595746 - Radiological Bone Loss on Different Levels of Dental Implants N/A
Completed NCT03357705 - Effectiveness in Limiting the Need to Elevate the Maxillary Sinus N/A
Recruiting NCT05311735 - Mineralized and Partial Demineralized Dentin Graft Compared to FDBA N/A
Completed NCT05494476 - Stability of the Marginal Bone Around Subcrestal Implants N/A
Not yet recruiting NCT05536479 - Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation N/A
Active, not recruiting NCT02275767 - Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft N/A
Active, not recruiting NCT02120053 - Interest of Bone Substitute Material in Immediate Complete Denture Phase 2/Phase 3
Completed NCT01728844 - GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery N/A
Terminated NCT00991432 - Localized Alveolar Ridge Augmentation With Space Maintenance Devices N/A
Terminated NCT00991965 - Localized Alveolar Ridge Augmentation With Dental Implant N/A