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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702609
• Other study ID #: CLP-2015-12-17-1
• Status: Completed
• Phase: N/A
• Start date: August 2, 2016
• Est. completion date: August 19, 2019

Study information

• Verified date: September 2020
• Source: Sunstar Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Ridge Preservation
• Dental Implants

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland School of Dentistry	Baltimore	Maryland
United States	The University of Iowa College of Dentistry	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Sunstar Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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