BonyPid-500TM Bone Graft Substitute Study

NCT02531100 | Completed

• 1 other identifier: BonyPid-201
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Peri Implantitis

Outcome Measures

Primary Outcomes (2)

• Safety: AEs (adverse events) as reported by the subject or observed by the Investigator,

  All AEs including any change in medical or dental status.

  12 months

• Effectiveness: the change in Pocket Probing Depth (cPPD) from baseline to 6 months, measured in mm.

  The primary effectiveness endpoint of the study is the change in Pocket Probing Depth (cPPD) from baseline to 6 months, measured in mm.

  6 months

Study Arms (2)

BonyPid-500TM implantation

EXPERIMENTAL

Standard of care (SOC) treatment (Manual and ultrasonic debridement and surface decontamination) followed by BonyPid-500TM implantation.

Device: BonyPid 500TM implantation concomitantly to SOC treatment; Other: SOC treatment only

SOC treatment

OTHER

Standard of care treatment (Manual and ultrasonic debridement and surface decontamination) only

Other: SOC treatment only

Interventions

BonyPid 500TM implantation concomitantly to SOC treatment DEVICE

BonyPid 500TM implantation concomitantly to SOC treatment

BonyPid-500TM implantation

SOC treatment only OTHER

Standard of care treatment (Manual and ultrasonic debridement, and surface decontamination)

BonyPid-500TM implantation; SOC treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Intrabony defect
• Bone loss ≥ 3 mm
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PolyPid Ltd.: lead
• MIS Implant Technologies, Ltd: collaborator

Study Sites (2)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Olga Belotserkovsky

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 24, 2015
• Study Start: March 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)