Endodontic TreatmentPhase 2IABNNCT01167985
A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment
A Phase 2 study testing IABN in people with Endodontic Treatment and Irreversible Pulpitis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in provisional restoration is going to be examined. Two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory the efficacy of provisional restoration during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment, Irreversible Pulpitis, Health Pulp
- What is being tested?
- IABN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Dec 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Needs root canal treatment
- For the provisional restoration- molar teeth with class II restoration
- For the provisional restoration-healty/ uninfected teeth
- For the root canal sealer- single root canal
- For root canal sealer-infected teeth
Who cannot join
- systemic health problems
- Pregnant women
- The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Arik Tzukhert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment
The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in provisional restoration is going to be examined. Two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory the efficacy of provisional restoration during root canal treatment.We assume, based on our previous laboratory studies that show antibacterial properties, that the incorporation of the nanoparticels will improve the treatment outcome.
Read the detailed description
- patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with (test group-40 patients) and without (control group- 40 patients) nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
- patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. Two study group (40 patients on each group) will have their canal sealed with a two types of endodontic sealers each + the nanoparticles. The control group (40 patients) will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups: 2 weeks, 3 months, 6 months and 1 year during which a clinical and radiological examinations will be performed.While preparing the post, a small example of the sealer will be taken to a test in the lab.
- Being tested
- IABN
- Keywords
- antibacterial polyethyleneimine nanoparticles, quaternary ammonium, dental, Endodotnic, pulp, bacteria, Root canal sealer, temporary filling, provisional restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IABNDevice
Also called QA-PEI
Patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.
IABNDevice
Also called QA-PEI
patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with and without nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
IABNDevice
Also called QA-PEI
Patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.
| Study group | Role | What they receive |
|---|---|---|
| Root canal sealer group+ IABN | Experimental | Device: alkylated polyethylenimine nanoparticles antibacterial evaluation Receives: Device: IABN |
| Provisional restoration material+ IABN | Experimental | Device: alkylated polyethylenimine nanoparticles antibacterial evaluation Receives: Device: IABN |
| Experimental- Different root canal sealer+ IABN | Experimental | Device: alkylated polyethylenimine nanoparticles antibacterial evaluation Receives: Device: IABN |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro evaluation
clinical and radiological evaluation of the radiolucent periapical lesion, for the root canal sealer. As for the provisional restoration, in vitro assesment of bacterial growth.
Measured: One month for provisional restoration.
Secondary outcomes (2)
Radiological evaluation of the root canal sealer
clinical and radiological evaluation of the radiolucent periapical lesion, for the root canal sealer. As for the provisional restoration, in vitro assesment of bacterial growth.
Measured: 1 year for the root canal sealer.
Clinical and in vitro evaluation of the root canal sealer
clinical and radiological evaluation of the radiolucent periapical lesion, for the root canal sealer. As for the provisional restoration, in vitro assesment of bacterial growth.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.
Measured: 1 year for the root canal sealer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perez Davidi Michael, Hadassah Medical Organization
- Investigators
- Michael Michael Perez Davidi, DMD, Principal investigator, Hadassah Medical OrganizationErvin Weiss, DMD, Study chair, Hadassah Medical OrganizationItzhak Abramovitz, DMD, Study chair, Hadassah Medical OrganizationDana Kesler Shvero, DMD, Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167985
- Sponsor's protocol ID
- 191062 HMO-CTIL
- Acronym
- IABN
- Status last verified
- Jul 2013
- First submitted
- 9 Jun 2010
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.
PubMed 16564083Slutsky H, Weiss EI, Lewinstein I, Slutzky S, Matalon S. Surface antibacterial properties of resin and resin-modified dental cements. Quintessence Int. 2007 Jan;38(1):55-61.
PubMed 17216909Matalon S, Weiss EI, Gozaly N, Slutzky H. Surface antibacterial properties of compomers. Eur Arch Paediatr Dent. 2006 Sep;7(3):136-41. doi: 10.1007/BF03262554.
PubMed 17140542Yudovin-Farber I, Beyth N, Nyska A, Weiss EI, Golenser J, Domb AJ. Surface characterization and biocompatibility of restorative resin containing nanoparticles. Biomacromolecules. 2008 Nov;9(11):3044-50. doi: 10.1021/bm8004897. Epub 2008 Sep 27.
PubMed 18821794Shvero DK, Davidi MP, Weiss EI, Srerer N, Beyth N. Antibacterial effect of polyethyleneimine nanoparticles incorporated in provisional cements against Streptococcus mutans. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):367-371. doi: 10.1002/jbm.b.31662.
PubMed 20583306
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment
- ClinicalTrials.gov ID
- NCT01167985
- Acronym / sponsor ID
- IABN / 191062 HMO-CTIL
- Keywords
- antibacterial polyethyleneimine nanoparticles, quaternary ammonium, dental, Endodotnic, pulp, bacteria, Root canal sealer, temporary filling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in provisional restoration is going to be examined. Two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory the efficacy of provisional restoration during root canal treatment.We assume, based on our previous laboratory studies that show antibacterial properties, that the incorporation of the nanoparticels will improve the treatment outcome.
Detailed description
- patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with (test group-40 patients) and without (control group- 40 patients) nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
- patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. Two study group (40 patients on each group) will have their canal sealed with a two types of endodontic sealers each + the nanoparticles. The control group (40 patients) will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups: 2 weeks, 3 months, 6 months and 1 year during which a clinical and radiological examinations will be performed.While preparing the post, a small example of the sealer will be taken to a test in the lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Root canal sealer group+ IABN | Experimental | Device: IABNDevice: alkylated polyethylenimine nanoparticles antibacterial evaluation |
| Provisional restoration material+ IABN | Experimental | Device: IABNDevice: alkylated polyethylenimine nanoparticles antibacterial evaluation |
| Experimental- Different root canal sealer+ IABN | Experimental | Device: IABNDevice: alkylated polyethylenimine nanoparticles antibacterial evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Needs root canal treatment
- For the provisional restoration- molar teeth with class II restoration
- For the provisional restoration-healty/ uninfected teeth
- For the root canal sealer- single root canal
- For root canal sealer-infected teeth
Key exclusion criteria (3 listed)
- systemic health problems
- Pregnant women
- The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IABNAlso: QA-PEIPatients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab. | Device | Root canal sealer group+ IABN |
| IABNAlso: QA-PEIpatients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with and without nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol. | Device | Provisional restoration material+ IABN |
| IABNAlso: QA-PEIPatients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab. | Device | Experimental- Different root canal sealer+ IABN |
Primary outcome
In vitro evaluation
Time frame: One month for provisional restoration.
clinical and radiological evaluation of the radiolucent periapical lesion, for the root canal sealer. As for the provisional restoration, in vitro assesment of bacterial growth.
2 secondary outcomes
Radiological evaluation of the root canal sealer
Time frame: 1 year for the root canal sealer.
Clinical and in vitro evaluation of the root canal sealer
Time frame: 1 year for the root canal sealer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Background: PubMed 16564083Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.
- Background: PubMed 17216909Slutsky H, Weiss EI, Lewinstein I, Slutzky S, Matalon S. Surface antibacterial properties of resin and resin-modified dental cements. Quintessence Int. 2007 Jan;38(1):55-61.
- Background: PubMed 17140542Matalon S, Weiss EI, Gozaly N, Slutzky H. Surface antibacterial properties of compomers. Eur Arch Paediatr Dent. 2006 Sep;7(3):136-41. doi: 10.1007/BF03262554.
- Background: PubMed 18821794Yudovin-Farber I, Beyth N, Nyska A, Weiss EI, Golenser J, Domb AJ. Surface characterization and biocompatibility of restorative resin containing nanoparticles. Biomacromolecules. 2008 Nov;9(11):3044-50. doi: 10.1021/bm8004897. Epub 2008 Sep 27.
- Background: PubMed 20583306Shvero DK, Davidi MP, Weiss EI, Srerer N, Beyth N. Antibacterial effect of polyethyleneimine nanoparticles incorporated in provisional cements against Streptococcus mutans. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):367-371. doi: 10.1002/jbm.b.31662.
- Michael Perez DavidiLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Michael Perez Davidi, DMD principal investigator
Hadassah Medical Organization
Ervin Weiss, DMD study chair
Hadassah Medical Organization
Itzhak Abramovitz, DMD study chair
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IABN in people with Endodontic Treatment and Irreversible Pulpitis, run by Hadassah Medical Organization at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Perez Davidi, DMD (00 972 3 9244859, michaelperezdavidi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro evaluation (time frame: One month for provisional restoration.). 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 NCT01167985, which also lists 5 linked publications.
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 23 Jul 2013.