Clinical trial NCT01167985: A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment
Official title: Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endodontic Treatment
Irreversible Pulpitis
Health Pulp
Infected Pulp
Keywords: antibacterial polyethyleneimine nanoparticles
quaternary ammonium
dental
Endodotnic
pulp
bacteria
Root canal sealer
temporary filling
provisional restoration
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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: 1. 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.
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.

Eligibility criteria: Inclusion Criteria:

1. Needs root canal treatment
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:

1. systemic health problems
2. Pregnant women
3. The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study

Primary outcomes:
measure: In vitro evaluation
timeFrame: One month for provisional restoration.
Secondary outcomes:
measure: Radiological evaluation of the root canal sealer
timeFrame: 1 year for the root canal sealer.
measure: Clinical and in vitro evaluation of the root canal sealer
timeFrame: 1 year for the root canal sealer.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Michael Perez Davidi, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Ervin Weiss, DMD
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Itzhak Abramovitz, DMD
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Dana Kesler Shvero, DMD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.