Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites

• Sponsor: Sunstar Americas (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03215667
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Actual Duration (Months): 27.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.

Condition or Disease	Intervention/Treatment	Phase
Alveolar Ridge Preservation; Dental Implants	Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ridge Preservation With Hardening Calcium Phosphate Bone Substitutes and Resorbable Membrane for Implant Site Development on Non-containable Extraction Sites: A Clinical and Histological Prospective Case Series in Humans
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Nov 3, 2019
• Actual Study Completion Date: Nov 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device treatment easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane	Device: easy-graft CLASSIC (beta-Tricalcium Phosphate); easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.; Other Names: GUIDOR Bioresorbable Matrix Barrier

Outcome Measures

Primary Outcome Measures

1. Change in Radiographic Measurements of Bone Ridge Dimensions [Change from Baseline at 3 months]

   Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.

Secondary Outcome Measures

1. Change in Digital Measurements of Soft Tissue Dimensions [Change from baseline at 5 months]

   Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study

• minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)

• single-rooted tooth to be extracted

• American Society of Anesthesiologists (ASA) Physical Status Classification I or II

• age >18 years old

• subjects who had >50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study

• adjacent teeth to extraction site will be present during healing period

• willingly sign informed consent and authorization.

Exclusion Criteria:

• do not meet any inclusion criteria

• pregnancy or nursing woman

• subjects with active systemic or localized infection (exclude chronic periodontitis)

• subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c>7%)

• subjects with smoking habit (more than 10 cigarettes per day)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University School of Dentistry	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Sunstar Americas

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 29, 2017

More Information

Publications

None provided.

• Responsible Party: Sunstar Americas
• ClinicalTrials.gov Identifier: NCT03215667
• Other Study ID Numbers: CLP-2016-11-07-1
• First Posted: Jul 12, 2017
• Last Update Posted: Jan 25, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Arm/Group Title	Device Treatment
Arm/Group Description	easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Period Title: Overall Study
STARTED	9
COMPLETED	5
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Device Treatment
Arm/Group Description	easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Overall Participants	9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (15.3)
Sex: Female, Male (Count of Participants)
Female	6 66.7%
Male	3 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	9 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 22.2%
White	7 77.8%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Radiographic Measurements of Bone Ridge Dimensions
Description	Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.
Time Frame	Change from Baseline at 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Treatment
Arm/Group Description	easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Measure Participants	5
Overall	1.59 (1.05)
1 mm below the alveolar bone crest	1.89 (1.03)

2. Secondary Outcome

Title	Change in Digital Measurements of Soft Tissue Dimensions
Description	Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements.
Time Frame	Change from baseline at 5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Treatment
Arm/Group Description	easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Measure Participants	5
Overall	0.99 (2.18)
1mm below the ridge crest	2.57 (1.35)

Adverse Events

Time Frame	5 months after ridge preservation surgery
Arm/Group Title	Device Treatment
Arm/Group Description	easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
All Cause Mortality
	Device Treatment
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Serious Adverse Events
	Device Treatment
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Device Treatment
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.