Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis

Periapical Diseases Clinical Trial

Official title:

Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02196740
• Other study ID #: Tri-antibiotic-2014
• Status: Active, not recruiting
• Phase: N/A
• First received: July 17, 2014
• Last updated: July 21, 2014
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periapical Diseases

Intervention

Drug:
• Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste
Pulp removal,Root canal irrigation and disinfection,
• creosote
Pulp removal,Root canal irrigation and disinfection

Locations

Country	Name	City	State
China	Jicheng Lin	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Lin Jiacheng

Country where clinical trial is conducted

China, 

References & Publications (3)

Bezgin T, Yilmaz AD, Celik BN, Sönmez 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of lesion healing confirmed by cone beam computed tomography and X-rays		1 year	No