Case Series of New Alloplastic Bone Graft Material

Oral Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221557
• Other study ID #: 2014-7-1-1
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: August 8, 2017
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: Sunstar Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Surgery
• Periodontology

Intervention

Device:
• easy-graft (beta-Tricalcium Phosphate)

Locations

Country	Name	City	State
United States	University of Maryland School of Dentistry	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sunstar Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Radiographic Measurement of Alveolar Ridge Height	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).	Change from baseline to 6 months