NCT00624572

Brief Summary

The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.

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
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

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

October 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 27, 2008

Status Verified

February 1, 2008

Enrollment Period

1.1 years

First QC Date

February 15, 2008

Last Update Submit

February 25, 2008

Conditions

Dental Pulp Necrosis

Keywords

primary teethchlorexidineroot canal therapyPulpectomy

Interventions

chlorexidineDRUG

Chlorexidine gel 1% during 7 days inside root canals

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children of both gender;
  • Without history of reactions or alergical diseases;
  • With situated age between 04 and 08 years of age
  • With normal standard of growth and development
  • Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.

You may not qualify if:

  • Patients with history of alergical diseases
  • Patients with allergy to any type of medicine and/or foods
  • Patients with comprometimento of its general state of health
  • Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
  • Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
  • With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
  • Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
  • Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramille Araújo Lima

Fortaleza, Ceará, 60440-810, Brazil

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

October 1, 2007

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

February 27, 2008

Record last verified: 2008-02

Locations

BR(1)