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OpenTrials
Completed

NCT Number: NCT03149172

Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Equimatrix®

Device

Ridge preservation bone grafting after tooth extraction

Bio-Oss®

Device

Ridge preservation bone grafting after tooth extraction

Endobon®

Device

Ridge preservation bone grafting after tooth extraction

Primary outcomes

  1. Percent New Bone Formation

    Time frame: 4-6 months after ridge preservation surgery

    Histomorphometric determination of % new bone formation

Secondary outcomes

  1. Bone Density

    Time frame: 4-6 months after ridge preservation surgery

    Measured by Micro CT Scanning

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 11, 2017
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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