Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

NCT ID: NCT03213210

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device treatment

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

Group Type: OTHER

easy-graft CLASSIC (beta-Tricalcium Phosphate)

Intervention Type: 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.

Interventions

easy-graft CLASSIC (beta-Tricalcium Phosphate)

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.

Intervention Type: DEVICE

Other Intervention Names

GUIDOR Bioresorbable Matrix Barrier

Eligibility Criteria

Inclusion Criteria

• 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:

1. Implant presenting Probing Depth ≥ 6 mm

2. Radiographic implant bone loss more than 25% of the implant length (Apex of the implant to implant platform) .

3. 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

4. Single tooth implant restoration or implant supported fixed partial denture.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunstar Americas

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Creighton University School of Dentisty

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLP-2017-02-18-1

Identifier Type: -

Identifier Source: org_study_id