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

NCT03215667 | Terminated Results FDA Device

• 1 other identifier: CLP-2016-11-07-1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Preservation; Dental Implants

Outcome Measures

Primary Outcomes (1)

• Change in Radiographic Measurements of Bone Ridge Dimensions

  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.

  Change from Baseline at 3 months

Secondary Outcomes (1)

• Change in Digital Measurements of Soft Tissue Dimensions

  Change from baseline at 5 months

Study Arms (1)

Device treatment

EXPERIMENTAL

easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane

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

Interventions

easy-graft CLASSIC (beta-Tricalcium Phosphate) DEVICE

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.

Also known as: GUIDOR Bioresorbable Matrix Barrier

Device treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Akane Takemura
• Organization: Sunstar Americas, Inc.

akane.takemura@us.sunstar.com

8477944276

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: July 10, 2017
• First Posted: July 12, 2017
• Study Start: August 1, 2017
• Primary Completion: November 3, 2019
• Study Completion: November 3, 2019
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)