NCT02196740

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

July 17, 2014

Last Update Submit

July 21, 2014

Conditions

Keywords

periapical periodontitis,primary teeth

Outcome Measures

Primary Outcomes (1)

  • Evidence of lesion healing confirmed by cone beam computed tomography and X-rays

    1 year

Study Arms (2)

creosote

ACTIVE COMPARATOR

Creosote ,once,three weeks Triple Antibiotic Paste ,none

Drug: creosote

Triple Antibiotic Paste

EXPERIMENTAL

Triple Antibiotic Paste,once,three weeks creosote,none

Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste

Interventions

Pulp removal,Root canal irrigation and disinfection,

Triple Antibiotic Paste

Pulp removal,Root canal irrigation and disinfection

Also known as: oily liquid obtained by distillation of wood tar
creosote

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • blood disease
  • residual root that is advised to extract
  • serious periodontitis
  • allergy to the triple antibiotic paste

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jicheng Lin

Guangzhou, Guangdong, 510055, China

Location

Related Publications (3)

  • 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.

    PMID: 23772873BACKGROUND
  • 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.

    PMID: 24767551BACKGROUND
  • 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.

    PMID: 24862703BACKGROUND

MeSH Terms

Conditions

Periapical DiseasesPeriapical Periodontitis

Interventions

Creosote

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jiacheng Lin

    Guanghua hospital of stomotology,Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 22, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations