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

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

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.

Study Overview

• Status: Terminated
• Conditions: Dental Implants; Alveolar Ridge Preservation
• Intervention / Treatment: Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Digital Measurements of Soft Tissue Dimensions	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.	Change from baseline at 5 months

Collaborators and Investigators

• Sponsor: Sunstar Americas

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 3, 2019
• Study Completion (Actual): November 3, 2019

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CLP-2016-11-07-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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