BonyPid-500TM Bone Graft Substitute Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02531100
• Date of registration: 20/08/2015
• Prospective Registration: Yes
• Primary sponsor: PolyPid Ltd.
• Public title: BonyPid-500TM Bone Graft Substitute Study
• Scientific title: PolyPid, Ltd. Pilot Study of the BonyPid-500TM Bone Graft Substitute
• Date of first enrolment: March 2016
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02531100
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Olga Belotserkovsky
• Affiliation: Sponsor GmbH

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peri Implantitis

Intervention(s)

Other: SOC treatment only

Device: BonyPid 500TM implantation concomitantly to SOC treatment

Primary Outcome(s)

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

Safety: AEs (adverse events) as reported by the subject or observed by the Investigator, [Time Frame: 12 months]

Secondary ID(s)

BonyPid-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MIS Implant Technologies, Ltd