Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System

Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket

Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.

Study Overview

• Status: Completed
• Conditions: Dental Implants; Alveolar Ridge Preservation
• Intervention / Treatment: Device: easy-graft CLASSIC; Device: FDBA with collagen plug

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa College of Dentistry
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of informed consent
• At least 18 years old
• In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
• Intact ridge as verified with cone-beam CT scan
• At least one natural tooth adjacent to the study site present.

Exclusion Criteria:

• Insufficient interocclusal space to allow for implant supported prosthesis
• Dehiscence or fenestration identified at the time of reviewing CBCT.
• Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
• Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
• Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
• Adjacent teeth (or tooth) to study site with significant soft tissue loss
• Smoker using more than 10 cigarettes or equivalent per day
• Smokeless tobacco use or e-cigarette use
• Current alcohol or drug abuser
• Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
• Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
• Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
• Unable or unwilling to return for follow-up visits for a period of 5 months
• Unlikely to be able to comply with study procedures according to Investigators judgement
• Subject in other clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moldable beta-TCP grafting system; Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)	Device: easy-graft CLASSIC; easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
Active Comparator: Allograft; Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug	Device: FDBA with collagen plug; FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)	Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)	Baseline and 4 months post-surgery
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)	Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.	Baseline and 4 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometric Assessment of Newly Formed Mineralized Tissue	Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of mineralized tissue respective to the percent of the total core area.	5 months post-surgery
Histomorphometric Assessment of Residual Bone Graft Particles	Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of residual bone graft respective to the percent of the total core area.	5 months post-surgery
Histomorphometric Assessment of Non-mineralized Tissue	Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of non-mineralized tissue respective to the percent of the total core area.	5 months post-surgery
Change of Marginal Bone Level Around Dental Implant	Linear measurement of marginal bone level (MBL) in millimeters along mesial and distal dental implant surface are captured in periapical standardized radiographs at crown delivery (baseline), 6, and 12 months after crown delivery. Change of MBL = (Baseline measurement - 6 or 12 months measurement)	Baseline, 6, and 12 months after crown delivery

Collaborators and Investigators

• Sponsor: Sunstar Americas

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2016
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CLP-2015-12-17-1

Plan for Individual participant data (IPD)

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