Back to resultsEfficacy of Synthetic Bone Graft for Treatment of Peri-implantitis
Primary Purpose
Peri-Implantitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
easy-graft CLASSIC (beta-Tricalcium Phosphate)
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
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:
- 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.
Sites / Locations
- Creighton University School of Dentisty
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Device treatment
Arm Description
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
Outcomes
Primary Outcome Measures
Change in Probing Depth
Distance of probe penetration from gingival margin to bottom of peri-implant pocket
Esthetic Satisfaction
To be assessed by examiner and subject using the Visual Analog Scales
Secondary Outcome Measures
Change of Marginal Bone Level
Change of marginal bone level on periapical standardized radiographs from baseline.
Change in Width of Keratinized Tissue
Distance between free gingival margin and mucogingival junction
Change in Clinical Attachment Level
Distance of probe penetration from fixed reference to bottom of peri-implant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03213210
Brief Title
Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis
Official Title
Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device treatment
Arm Type
Other
Arm Description
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
Intervention Type
Device
Intervention Name(s)
easy-graft CLASSIC (beta-Tricalcium Phosphate)
Other Intervention Name(s)
GUIDOR Bioresorbable Matrix Barrier
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Probing Depth
Description
Distance of probe penetration from gingival margin to bottom of peri-implant pocket
Time Frame
Change from baseline at 12 months after the surgery
Title
Esthetic Satisfaction
Description
To be assessed by examiner and subject using the Visual Analog Scales
Time Frame
At 12 months after the surgery
Secondary Outcome Measure Information:
Title
Change of Marginal Bone Level
Description
Change of marginal bone level on periapical standardized radiographs from baseline.
Time Frame
Change from baseline at 6 and 12 months after the surgery
Title
Change in Width of Keratinized Tissue
Description
Distance between free gingival margin and mucogingival junction
Time Frame
Change from baseline at 6 and 12 months after the surgery
Title
Change in Clinical Attachment Level
Description
Distance of probe penetration from fixed reference to bottom of peri-implant
Time Frame
Change from baseline to at 6 and 12 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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:
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.
Facility Information:
Facility Name
Creighton University School of Dentisty
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis
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