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

NCT02702609 | Completed Results

• 1 other identifier: CLP-2015-12-17-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dental Implants; Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Histomorphometric Assessment of Newly Formed Mineralized Tissue

  5 months post-surgery

• Histomorphometric Assessment of Residual Bone Graft Particles

  5 months post-surgery

• Histomorphometric Assessment of Non-mineralized Tissue

  5 months post-surgery

• Change of Marginal Bone Level Around Dental Implant

  Baseline, 6, and 12 months after crown delivery

Study Arms (2)

Moldable beta-TCP grafting system

EXPERIMENTAL

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

Device: easy-graft CLASSIC

Allograft

ACTIVE COMPARATOR

Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug

Device: FDBA with collagen plug

Interventions

easy-graft CLASSIC DEVICE

easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.

Moldable beta-TCP grafting system

FDBA with collagen plug DEVICE

FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.

Allograft

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (2)

The University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, 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: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: August 2, 2016
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)