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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03074136 |
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Date of registration:
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11/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Application of Photodynamic Therapy and Diode Laser for Endodontic Therapy of Young Permanent Teeth
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Scientific title:
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Application Success of Photodynamic Therapy and Diode Laser During Endodontic Therapy of Young Permanent Teeth |
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Date of first enrolment:
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February 10, 2017 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03074136 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Serbia
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Key inclusion & exclusion criteria
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Inclusion criteria
- a non-vital permanent immature single rooted tooth
- primary endodontic infection
- 6 - 18 years old
- written informed consent obtained from each parent and child
Exclusion criteria
- uncontrolled diabetes mellitus,
- immunosuppression,
- severe asthma
- usage of antibiotics, anti-inflammatory, corticosteroid, or immunosuppressive therapy
during the last 6 months
- need for antibiotics at current endodontic therapy
- need for antibiotics in prophylaxis of systematic disease before endodontic therapy
- periodontal diseases
- impossible adequate isolation of the tooth
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Teeth, Endodontically-Treated
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Intervention(s)
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Device: Photodinamic therapy
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Drug: 0.5% Sodium hypochlorite
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Device: Diode laser
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Primary Outcome(s)
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Number of teeth without viable bacteria load in root canal after Photodynamic therapy and Diode laser in endodontic therapy
[Time Frame: 6 months]
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Secondary Outcome(s)
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Number of teeth with periapical healing 6 months after treatment, assessed by periapical index (PAI)
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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