NCT02221557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 10, 2017

Completed
Last Updated

August 10, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

August 14, 2014

Results QC Date

July 10, 2017

Last Update Submit

August 8, 2017

Conditions

PeriodontologyOral Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

New alloplastic bone graft material

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

Interventions

easy-graft (beta-Tricalcium Phosphate)DEVICE
New alloplastic bone graft material

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have read, understood and signed a consent form.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Results Point of Contact

Title
Akane Takemura, R&D Senior Manager
Organization
Sunstar Americas, Inc.
akane.takemura@us.sunstar.com
847-794-4276

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 20, 2014

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 10, 2017

Results First Posted

August 10, 2017

Record last verified: 2017-07

Locations

US(1)