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Peri ImplantitisNCT02531100

BonyPid-500TM Bone Graft Substitute Study

A study testing BonyPid 500TM implantation concomitantly to SOC treatment and SOC treatment only in people with Peri Implantitis, run by PolyPid Ltd. at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Peri Implantitis
What is being tested?
BonyPid 500TM implantation concomitantly to SOC treatment and SOC treatment only
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesIsrael
Study dates
Mar 2016to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: PolyPid, Ltd. Pilot Study of the BonyPid-500TM Bone Graft Substitute

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.

Read the 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.

Being tested
BonyPid 500TM implantation concomitantly to SOC treatment, SOC treatment only
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BonyPid 500TM implantation concomitantly to SOC treatmentDevice

    BonyPid 500TM implantation concomitantly to SOC treatment

  • SOC treatment onlyOther

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

Study groups in NCT02531100
Study groupRoleWhat they receive
BonyPid-500TM implantationExperimentalStandard of care (SOC) treatment (Manual and ultrasonic debridement and surface decontamination) followed by BonyPid-500TM implantation.
Receives: Device: BonyPid 500TM implantation concomitantly to SOC treatment; Other: SOC treatment only
SOC treatmentOtherStandard of care treatment (Manual and ultrasonic debridement and surface decontamination) only
Receives: Other: SOC treatment only

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    All AEs including any change in medical or dental status.

    Measured: 12 months

  2. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2015 (estimated)
  2. Study startMar 2016
  3. Primary completionMay 2018
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531100
Sponsor's protocol ID
BonyPid-201
Status last verified
Jun 2018
First submitted
20 Aug 2015
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BonyPid 500TM implantation concomitantly to SOC treatment and SOC treatment only in people with Peri Implantitis, run by PolyPid Ltd. at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: AEs (adverse events) as reported by the subject or observed by the Investigator, (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02531100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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