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

• Sponsor: Lin Jiacheng (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02196740
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periapical Diseases	Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste; Drug: creosote	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: creosote Creosote ，once，three weeks Triple Antibiotic Paste ，none	Drug: creosote; Pulp removal,Root canal irrigation and disinfection; Other Names: oily liquid obtained by distillation of wood tar
Experimental: Triple Antibiotic Paste Triple Antibiotic Paste,once,three weeks creosote,none	Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste; Pulp removal,Root canal irrigation and disinfection,

Outcome Measures

Primary Outcome Measures

1. Evidence of lesion healing confirmed by cone beam computed tomography and X-rays [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jicheng Lin	Guangzhou	Guangdong	China	510055

Sponsors and Collaborators

• Lin Jiacheng

Investigators

• Study Chair: Jiacheng Lin, Guanghua hospital of stomotology,Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Lin Jiacheng, Research Associate, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02196740
• Other Study ID Numbers: Tri-antibiotic-2014
• First Posted: Jul 22, 2014
• Last Update Posted: Jul 22, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Lin Jiacheng, Research Associate, Sun Yat-sen University: periapical periodontitis,primary teeth
• Additional relevant MeSH terms: Periapical Diseases; Metronidazole; Ciprofloxacin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gatifloxacin

Study Results

No Results Posted as of Jul 22, 2014