- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196740
Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis
July 21, 2014 updated by: Lin Jiacheng
Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510055
- Jicheng Lin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: creosote
Creosote ,once,three weeks Triple Antibiotic Paste ,none
|
Pulp removal,Root canal irrigation and disinfection
Other Names:
|
|
Experimental: Triple Antibiotic Paste
Triple Antibiotic Paste,once,three weeks creosote,none
|
Pulp removal,Root canal irrigation and disinfection,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evidence of lesion healing confirmed by cone beam computed tomography and X-rays
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jiacheng Lin, Guanghua hospital of stomotology,Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
July 17, 2014
First Submitted That Met QC Criteria
July 21, 2014
First Posted (Estimate)
July 22, 2014
Study Record Updates
Last Update Posted (Estimate)
July 22, 2014
Last Update Submitted That Met QC Criteria
July 21, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Jaw Diseases
- Periapical Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Pharmaceutical Solutions
- Cytochrome P-450 CYP1A2 Inhibitors
- Ophthalmic Solutions
- Metronidazole
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Ciprofloxacin
- Gatifloxacin
Other Study ID Numbers
- Tri-antibiotic-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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