Back to resultsResearch of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis
Primary Purpose
Periapical Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste
creosote
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Diseases focused on measuring periapical periodontitis,primary teeth
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of periapical periodontitis
- must be primary teeth
- must be 3~8 years old
- the permanent tooth germ is complete and didnot be involved
Exclusion Criteria:
- blood disease
- residual root that is advised to extract
- serious periodontitis
- allergy to the triple antibiotic paste
Sites / Locations
- Jicheng Lin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
creosote
Triple Antibiotic Paste
Arm Description
Creosote ，once，three weeks Triple Antibiotic Paste ，none
Triple Antibiotic Paste,once,three weeks creosote,none
Outcomes
Primary Outcome Measures
Evidence of lesion healing confirmed by cone beam computed tomography and X-rays
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02196740
Brief Title
Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis
Official Title
Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lin Jiacheng
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in the treatment of periapical periodontitis of deciduous teeth is superior to other drugs currently in use as creosote.
Detailed Description
We design to collect a group of patients presenting primary teeth with periapical periodontitis in certain criterion. We will divide the patients into two groups randomly.One group will get treated with triple antibiotic paste while the other with creosote.We want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of triple antibiotic paste.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases
Keywords
periapical periodontitis,primary teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
creosote
Arm Type
Active Comparator
Arm Description
Creosote ，once，three weeks Triple Antibiotic Paste ，none
Arm Title
Triple Antibiotic Paste
Arm Type
Experimental
Arm Description
Triple Antibiotic Paste,once,three weeks creosote,none
Intervention Type
Drug
Intervention Name(s)
Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste
Intervention Description
Pulp removal,Root canal irrigation and disinfection,
Intervention Type
Drug
Intervention Name(s)
creosote
Other Intervention Name(s)
oily liquid obtained by distillation of wood tar
Intervention Description
Pulp removal,Root canal irrigation and disinfection
Primary Outcome Measure Information:
Title
Evidence of lesion healing confirmed by cone beam computed tomography and X-rays
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of periapical periodontitis
must be primary teeth
must be 3~8 years old
the permanent tooth germ is complete and didnot be involved
Exclusion Criteria:
blood disease
residual root that is advised to extract
serious periodontitis
allergy to the triple antibiotic paste
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiacheng Lin
Organizational Affiliation
Guanghua hospital of stomotology,Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Jicheng Lin
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510055
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23772873
Citation
Bezgin T, Yilmaz AD, Celik BN, Sonmez H. Concentrated platelet-rich plasma used in root canal revascularization: 2 case reports. Int Endod J. 2014 Jan;47(1):41-9. doi: 10.1111/iej.12144. Epub 2013 Jun 17.
Results Reference
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PubMed Identifier
24767551
Citation
Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
Results Reference
background
PubMed Identifier
24862703
Citation
Nagata JY, Soares AJ, Souza-Filho FJ, Zaia AA, Ferraz CC, Almeida JF, Gomes BP. Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization. J Endod. 2014 Jun;40(6):778-83. doi: 10.1016/j.joen.2014.01.038. Epub 2014 Apr 29.
Results Reference
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Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis
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