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Trial record 1 of 7 for:    POLYPID
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BonyPid-500TM Bone Graft Substitute Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531100
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
MIS Implant Technologies, Ltd
Information provided by (Responsible Party):
PolyPid Ltd.

Tracking Information
First Submitted Date  ICMJE August 20, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date June 26, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
  • Safety: AEs (adverse events) as reported by the subject or observed by the Investigator, [ Time Frame: 12 months ]
    All AEs including any change in medical or dental status.
  • Effectiveness: the change in Pocket Probing Depth (cPPD) from baseline to 6 months, measured in mm. [ Time Frame: 6 months ]
    The primary effectiveness endpoint of the study is the change in Pocket Probing Depth (cPPD) from baseline to 6 months, measured in mm.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BonyPid-500TM Bone Graft Substitute Study
Official Title  ICMJE PolyPid, Ltd. Pilot Study of the BonyPid-500TM Bone Graft Substitute
Brief Summary

This study is designed to assess the safety and effectiveness of BonyPid-500TM implantation for intrabony peri-implantitis defects.

BonyPid-500™ is a bone graft substitute, which contains an antibiotic drug - doxycycline, and is intended for filling and reconstruction of bone defects caused by peri-implantitis.

Detailed Description

This is a pilot, randomized, single-blind, two arm controlled, multicenter study in subjects undergoing surgical treatment for peri-implantitis disease. Eligible subjects will undergo a surgical treatment and be randomly assigned during surgical intervention (after flap opening) in a 1:1 ratio to adjunct BonyPid-500TM implantation or no BonyPid-500TM implantation.

Randomization will be stratified by site and number of eligible implants, i.e., single or multiple.

The study population includes male and female subjects, 20 - 80 years of age at screening, diagnosed with peri-implantitis and recommended for surgical treatment of peri-implantitis disease.

Up to 77 subjects will be enrolled to this study which will be conducted in two medical centers in Israel.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Peri Implantitis
Intervention  ICMJE
  • Device: BonyPid 500TM implantation concomitantly to SOC treatment
    BonyPid 500TM implantation concomitantly to SOC treatment
  • Other: SOC treatment only
    Standard of care treatment (Manual and ultrasonic debridement, and surface decontamination)
Study Arms  ICMJE
  • Experimental: BonyPid-500TM implantation
    Standard of care (SOC) treatment (Manual and ultrasonic debridement and surface decontamination) followed by BonyPid-500TM implantation.
    Interventions:
    • Device: BonyPid 500TM implantation concomitantly to SOC treatment
    • Other: SOC treatment only
  • SOC treatment
    Standard of care treatment (Manual and ultrasonic debridement and surface decontamination) only
    Intervention: Other: SOC treatment only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2018)
27
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2015)
77
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and Female subjects, 20 - 80 years of age at screening.
  • Females of childbearing potential must have a negative urine pregnancy test before radiographs, dental hygienist cleaning, and surgical procedure (Note: Females of childbearing age must agree to use a highly effective method of contraception consistently and correctly for the duration of the study period).
  • Subjects with a minimum of one osseo-integrated implant with peri-implantitis.
  • Subjects with at least one eligible implant within the surgical area.
  • Subjects with bleeding on probing of selected implant with or without suppuration.
  • Subjects with selected implant(s) having radiographic evidence, according to X-rays, of:

    1. Intrabony defect
    2. Bone loss ≥ 3 mm
    3. Minimum of 2 mm of bone at implant apex.
  • Subjects must be willing and able to provide a written informed consent prior to any protocol specific procedures being performed and comply with protocol requirements.

Exclusion Criteria:

  • Subjects with hydroxyapatite (HA) coated implants, titanium plasma spray implants.
  • Subjects with a distance between implants < 3 mm, or < 2 mm between implant and tooth.
  • Subjects with implants supporting removable dentures.
  • Subjects presenting with severe active periodontitis.
  • Subjects with poor oral hygiene.
  • Subjects with selected implant(s) with radiographic evidence of horizontal bone loss only.
  • Subjects suffering from Type 1 (insulin dependent) diabetes; or uncontrolled Type 2 diabetes. Diabetic subjects must provide a statement from a physician regarding the status of diabetes, in addition to a recent (within 3 months) documented Hemoglobin (Hgb) A1c blood test of < 6.5%.
  • Pregnant women or women who intend to become pregnant during the study period, or breastfeeding women.
  • Subjects with known allergy or contraindication to tetracycline(s).
  • Subjects who are current smokers or who were smokers within 3 months prior to screening.
  • Subjects who were under oral or local antibiotic therapy in the last 4 weeks prior to study enrollment.
  • Subjects treated for at least 2 weeks with any medication known to affect soft tissue condition within one month prior to study enrollment (e.g., Phenytoin, Cyclosporine, Coumadin, and NSAIDs).
  • Subjects treated with Oral or IV use of doxycycline in the last four weeks prior to screening.
  • Subjects with presence of active systemic infectious diseases such as: hepatitis, HIV, or a history of tuberculosis.
  • Subjects with any condition, which in the opinion of the Investigator, would place the subject at risk or influence the conduct of the study or interpretation of results.
  • Subjects who are incapable of following the study schedule for any reason, per the Investigator's discretion.
  • Subjects who are currently enrolled, recently participated (within 30 days prior to screening), or planning to enroll in another study that may conflict with protocol requirements or may confound the subject results in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531100
Other Study ID Numbers  ICMJE BonyPid-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PolyPid Ltd.
Study Sponsor  ICMJE PolyPid Ltd.
Collaborators  ICMJE MIS Implant Technologies, Ltd
Investigators  ICMJE
Study Director: Olga Belotserkovsky Sponsor GmbH
PRS Account PolyPid Ltd.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP