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Completed

NCT Number: NCT02221557

Case Series of New Alloplastic Bone Graft Material

A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.

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Key information

Conditions

Periodontology Oral Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have read, understood and signed a consent form.
  • 18-75 years of age
  • Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.

Exclusion criteria

  • Active caries or endodontic lesions in adjacent teeth
  • Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
  • Taking any medication known for gingival hyperplasia for past 3 months.
  • Any systemic contraindications to surgery
  • Subject smokes > 10 cigarettes per day.

Treatment and study plan

easy-graft (beta-Tricalcium Phosphate)

Device

Primary outcomes

  1. Percentage Change in Radiographic Measurement of Alveolar Ridge Height

    Time frame: Change from baseline to 6 months

    Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).

Sponsors and collaborators

Lead sponsor

Sunstar Americas

Industry

Registry information

Official study title

Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2014
Registry last updated
Aug 10, 2017

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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