Main
|
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. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
2 May 2016 |
Main ID: |
NCT02747082 |
Date of registration:
|
21/03/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Antibacterial Effectiveness of Two Root Canal Irrigants
|
Scientific title:
|
Antibacterial Effectiveness of Two Root Canal Irrigants in Root-filled Teeth With Infection: A Randomized Clinical Trial |
Date of first enrolment:
|
January 2012 |
Target sample size:
|
49 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02747082 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
Norway
| | | | | | | |
Contacts
|
Name:
|
Dag MR Ørstavik, DDS, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Chair of the endodontic department, University of Oslo |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Clinical diagnosis of apical periodontitis in a root-filled tooth assessed by
radiography.
Exclusion Criteria:
- Presence of gross carious lesions in the diagnosed tooth,
- Presence of fractures involving the periodontium of the diagnosed tooth,
- Presence of periodontal pockets more than 4 mm deep in the diagnosed tooth,
- Diagnosis of diabetes,
- Diagnosis of HIV infection,
- Other immunocompromising disease,
- Antibiotic therapy within the previous 3 months.
Age minimum:
20 Years
Age maximum:
95 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Periapical Periodontitis
|
Intervention(s)
|
Procedure: Retreatment of root-filled teeth with infection
|
Primary Outcome(s)
|
Periapical radiolucency (PAI- and Friedman-scores)
[Time Frame: 12 months]
|
Secondary Outcome(s)
|
Pyrosequencing of species found before and after the intervention
[Time Frame: 21 days]
|
Bacterial load assessed by qPCR
[Time Frame: 21 days]
|
Secondary ID(s)
|
2012/364/REK
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|