Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03213210
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : November 19, 2018
Information provided by (Responsible Party):
Sunstar Americas

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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Device: easy-graft CLASSIC (beta-Tricalcium Phosphate) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Device treatment
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
Device: 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.
Other Name: GUIDOR Bioresorbable Matrix Barrier

Primary Outcome Measures :
  1. Change in probing depth [ Time Frame: Change from baseline at 12 months after the surgery ]
    Distance of probe penetration from gingival margin to bottom of peri-implant pocket

  2. Esthetic satisfaction [ Time Frame: At 12 months after the surgery ]
    To be assessed by examiner and subject using the Visual Analog Scales

Secondary Outcome Measures :
  1. Change in clinical attachment level [ Time Frame: Change from baseline to at 6 and 12 months after the surgery ]
    Distance of probe penetration from fixed reference to bottom of peri-implant

  2. Change in width of keratinized tissue [ Time Frame: Change from baseline at 6 and 12 months after the surgery ]
    Distance between free gingival margin and mucogingival junction

  3. Bone gain [ Time Frame: Change from baseline at 6 and 12 months after the surgery ]
    Change of marginal bone level on periapical standardized radiographs

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03213210

Contact: Lorenzo Mordini, DDS 402-280-5085

United States, Nebraska
Creighton University School of Dentisty Recruiting
Omaha, Nebraska, United States, 68178
Contact: Lorenzo Mordini, DDS    402-280-5085   
Sponsors and Collaborators
Sunstar Americas

Responsible Party: Sunstar Americas Identifier: NCT03213210     History of Changes
Other Study ID Numbers: CLP-2017-02-18-1
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases