Case Series of New Alloplastic Bone Graft Material

Not Applicable

Completed

• Conditions: Periodontology; Oral Surgery
• Interventions: Device: easy-graft (beta-Tricalcium Phosphate)

• Registration Number: NCT02221557
• Lead Sponsor: Sunstar Americas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-20
• Study Start: 2015-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Results First Submitted: 2017-07-10
• Results First Submitted QC: 2017-08-08
• Last Update Submitted: 2017-08-08
• Results First Posted: 2017-08-10
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New alloplastic bone graft material	easy-graft (beta-Tricalcium Phosphate)	-

Primary Outcome Measures

Name	Time	Method
Percentage Change in Radiographic Measurement of Alveolar Ridge Height	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).

Trial Locations

Locations (1)

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States