Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

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

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.

Study Overview

• Status: Terminated
• Conditions: Peri-Implantitis
• Intervention / Treatment: Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University School of Dentisty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: GUIDOR Bioresorbable Matrix Barrier

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunstar Americas

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: CLP-2017-02-18-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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