Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device treatment<br>easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane | Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)<br>* 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.<br>* Other names: GUIDOR Bioresorbable Matrix Barrier;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Marginal Bone Level | Change of marginal bone level on periapical standardized radiographs from baseline. | Change from baseline at 6 and 12 months after the surgery | 
| Change in Width of Keratinized Tissue | Distance between free gingival margin and mucogingival junction | Change from baseline at 6 and 12 months after the surgery | 
| Change in Clinical Attachment Level | Distance of probe penetration from fixed reference to bottom of peri-implant | Change from baseline to at 6 and 12 months after the surgery |