A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment
NCT ID: NCT01167985
Last Updated: 2013-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2013-07-31
2015-12-31
Brief Summary
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Detailed Description
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2. 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Root canal sealer group+ IABN
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
IABN
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.
Provisional restoration material+ IABN
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
IABN
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.
Experimental- Different root canal sealer+ IABN
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
IABN
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.
Interventions
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IABN
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.
IABN
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.
IABN
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For the provisional restoration- molar teeth with class II restoration
3. For the provisional restoration-healty/ uninfected teeth
4. For the root canal sealer- single root canal
5. For root canal sealer-infected teeth
Exclusion Criteria
2. Pregnant women
3. The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study
18 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Perez Davidi Michael
DMD
Principal Investigators
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Michael Michael Perez Davidi, DMD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Ervin Weiss, DMD
Role: STUDY_CHAIR
Hadassah Medical Organization
Itzhak Abramovitz, DMD
Role: STUDY_CHAIR
Hadassah Medical Organization
Dana Kesler Shvero, DMD
Role: STUDY_CHAIR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Slutsky 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.
Matalon 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.
Yudovin-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.
Shvero 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.
Related Links
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Michael Perez Davidi
Other Identifiers
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191062 HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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