NCT03588351

Brief Summary

Aim of the present study is to assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticles ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

January 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

July 5, 2018

Last Update Submit

July 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticals ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars.

    antibacterial effect of Chlorhexidine Gluconate, Chitosan,Chitosan Nanoparticl on necrotic primary tooth

    3 month

Study Arms (3)

chlorhexidine gluconate

ACTIVE COMPARATOR

GROUP I: - 15 teeth will be treated with specially prepared gel containing chlorhexidine gluconate as intracanal medicament .

Drug: chlorhexidine gluconate

chitosan nanoparticles gel

EXPERIMENTAL

GROUP II: - 15 teeth will be treated with specially prepared gel containing chitosan nanoparticles that ready to use as intracanal medicament.

Drug: chitosan nanoparticles gel

chitosan gel

EXPERIMENTAL

Group III: 15teeth will be treated with specially prepared gell containing chitosan that ready to use as intra medicament .

Drug: chitosan gel

Interventions

intracanal medicament

Also known as: CSNPs
chitosan nanoparticles gel

intracanal medicament

Also known as: CS
chitosan gel

intracanal medicament

Also known as: CHX
chlorhexidine gluconate

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Apparently healthy children.
  • Age 4-7 years
  • Children should have at least one non vital and restorable mandibular molar .
  • Cooperative children.
  • Children that did not take any antibiotic for at least one month before sample collection

You may not qualify if:

  • Medically compromised children.
  • Children under antibiotic therapy.
  • Non restorable molars.
  • Root resorption more then half of the root length.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shames university faculty of dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marwa A Abozed, BDSC

    Faculty of Dentistry Ain shams University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marwa Ahmed Abozed

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 17, 2018

Study Start

January 1, 2018

Primary Completion

August 15, 2018

Study Completion

August 30, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations