Endodontic Treatment, Health Pulp, Infected Pulp, Irreversible Pulpitis
Conditions
Keywords
antibacterial polyethyleneimine nanoparticles, quaternary ammonium, dental, Endodotnic, pulp, bacteria, Root canal sealer, temporary filling, provisional restoration
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.
Interventions
DEVICEIABN
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.
Sponsors
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In vitro evaluation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological evaluation of the root canal sealer | 1 year for 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. |
| Clinical and in vitro evaluation of the root canal sealer | 1 year for 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. |
Countries
Israel
Contacts
Primary ContactMichael Perez Davidi, DMD
Backup ContactDana Kesler Shvwero, DMD
Outcome results
None listed