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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03215667
• Other study ID #: CLP-2016-11-07-1
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: November 3, 2019

Study information

• Verified date: January 2021
• Source: Sunstar Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 3, 2019
• Est. primary completion date: November 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alveolar Ridge Preservation
• Dental Implants

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana

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 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	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