Peri-Implantitis
Conditions
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.
Interventions
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.
Sponsors
Sunstar Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Depth | Change from baseline at 12 months after the surgery | Distance of probe penetration from gingival margin to bottom of peri-implant pocket |
| Esthetic Satisfaction | At 12 months after the surgery | To be assessed by examiner and subject using the Visual Analog Scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Marginal Bone Level | Change from baseline at 6 and 12 months after the surgery | Change of marginal bone level on periapical standardized radiographs from baseline. |
| Change in Width of Keratinized Tissue | Change from baseline at 6 and 12 months after the surgery | Distance between free gingival margin and mucogingival junction |
| Change in Clinical Attachment Level | Change from baseline to at 6 and 12 months after the surgery | Distance of probe penetration from fixed reference to bottom of peri-implant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Treatment easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
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. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Study termination | 3 |
Baseline characteristics
| Characteristic | Device Treatment |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in Probing Depth
Distance of probe penetration from gingival margin to bottom of peri-implant pocket
Time frame: Change from baseline at 12 months after the surgery
Population: No subjects were examined at 12 months after the surgery.
Primary
Esthetic Satisfaction
To be assessed by examiner and subject using the Visual Analog Scales
Time frame: At 12 months after the surgery
Population: No subjects were examined at 12 months after the surgery.
Secondary
Change in Clinical Attachment Level
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
Population: No subjects were examined at 6 and 12 months after the surgery.
Secondary
Change in Width of Keratinized Tissue
Distance between free gingival margin and mucogingival junction
Time frame: Change from baseline at 6 and 12 months after the surgery
Population: No subjects were examined at 6 and 12 months after the surgery.
Secondary
Change of Marginal Bone Level
Change of marginal bone level on periapical standardized radiographs from baseline.
Time frame: Change from baseline at 6 and 12 months after the surgery
Population: Marginal bone level was examined in 3 subjects at 6-month follow-up. No subjects were examined at 12 months after the surgery.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Treatment | Change of Marginal Bone Level | 6 months | 3.3 percentage of bone height change | Standard Deviation 5.8 |