Clinical trial NCT03213210: 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
Overall status: TERMINATED
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Probing Depth
timeFrame: Change from baseline at 12 months after the surgery
measure: Esthetic Satisfaction
timeFrame: At 12 months after the surgery
Secondary outcomes:
measure: Change of Marginal Bone Level
timeFrame: Change from baseline at 6 and 12 months after the surgery
measure: Change in Width of Keratinized Tissue
timeFrame: Change from baseline at 6 and 12 months after the surgery
measure: Change in Clinical Attachment Level
timeFrame: Change from baseline to at 6 and 12 months after the surgery
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University School of Dentisty
state: Nebraska
Study officials:
References: