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

Not Applicable

Completed

• Conditions: Alveolar Ridge Preservation; Dental Implants
• Interventions: Device: easy-graft CLASSIC; Device: FDBA with collagen plug

• Registration Number: NCT02702609
• Lead Sponsor: Sunstar Americas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-08
• Study Start: 2016-08-02
• Primary Completion: 2019-08-19
• Study Completion: 2019-08-19
• Status Verified: 2020-09
• Results First Submitted: 2020-09-29
• Results First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moldable beta-TCP grafting system	easy-graft CLASSIC	Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
Allograft	FDBA with collagen plug	Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug

Primary Outcome Measures

Name	Time	Method
Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)	Baseline and 4 months post-surgery	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)
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)	Baseline and 4 months post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
Histomorphometric Assessment of Newly Formed Mineralized Tissue	5 months post-surgery	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.
Histomorphometric Assessment of Non-mineralized Tissue	5 months post-surgery	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.
Change of Marginal Bone Level Around Dental Implant	Baseline, 6, and 12 months after crown delivery	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)
Histomorphometric Assessment of Residual Bone Graft Particles	5 months post-surgery	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.

Trial Locations

Locations (2)

The University of Iowa College of Dentistry; 🇺🇸 Iowa City, Iowa, United States

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States