Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

NCT03213210 | Terminated Results FDA Device

• 1 other identifier: CLP-2017-02-18-1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

• Change in Probing Depth

  Distance of probe penetration from gingival margin to bottom of peri-implant pocket

  Change from baseline at 12 months after the surgery

• Esthetic Satisfaction

  To be assessed by examiner and subject using the Visual Analog Scales

  At 12 months after the surgery

Secondary Outcomes (3)

• Change of Marginal Bone Level

  Change from baseline at 6 and 12 months after the surgery

• Change in Width of Keratinized Tissue

  Change from baseline at 6 and 12 months after the surgery

• Change in Clinical Attachment Level

  Change from baseline to at 6 and 12 months after the surgery

Study Arms (1)

Device treatment

OTHER

easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane

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

Interventions

easy-graft CLASSIC (beta-Tricalcium Phosphate) DEVICE

easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.

Also known as: GUIDOR Bioresorbable Matrix Barrier

Device treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has read and signed the Institutional Review Board approved consent form before treatment.
• Subject must be age 21 or above.
• Subject must be willing and able to follow study procedures and instructions.
• Subject affected by moderate to severe peri-implant disease.
• Treated chronic periodontitis and proper periodontal maintenance care.
• Dental implant must meet the following criteria to be selected for the study:
• Implant presenting Probing Depth ≥ 6 mm
• Radiographic implant bone loss more than 25% of the implant length (Apex of the implant to implant platform) .
• Peri implant bone defect being a buccal dehiscence and semicircular bone resorption to the middle of the implant body, buccal dehiscence and circular bone resorption with lingual bone plate intact or circular bone resorption with buccal and lingual bone plates intact
• Single tooth implant restoration or implant supported fixed partial denture.

You may not qualify if:

• Subjects participating (currently or within 30 days prior to enrollment) in other clinical trials involving therapeutic intervention (either medical or dental).
• Subjects with poor oral hygiene as indicated by a score of greater than 50% on the O'Leary Plaque Index.
• Subjects with a systemic condition, which would preclude periodontal treatment, including but not limited to uncontrolled diabetes.
• Subjects with acute infectious lesions in the areas intended for treatment.
• Subjects taking chronic (i.e., \> 2 weeks), therapeutic doses of medications known to affect bone metabolism such as nonsteroidal anti-inflammatory drugs or bisphosphonates. Prophylactic aspirin (≤ 325 mg q.d.) for cardiovascular indications will be permitted in subjects.
• Female subjects who are pregnant or lactating, or sexually-active female subjects who are of childbearing potential and are not using hormonal or barrier methods of birth control. (except for when a result of pregnancy test is negative)
• Subjects who are on any chronic antibiotic or steroidal therapy.
• Smoker using more than 10 cigarettes or equivalent per day.
• Smoker using cigar, smokeless tobacco use or e-cigarette.
• Subjects diagnosed with drug induced gingival hyperplasia (e.g. calcium channel blockers).
• Subjects with radiographic evidence of pathology in other areas of the mouth besides implant area to be treated.
• Implant mobility.
• Subjects with parafunctional habits and not wearing bite guard.

Sponsors & Collaborators

• Sunstar Americas: lead

Study Sites (1)

Creighton University School of Dentisty

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: November 12, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: April 8, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)