NCT05657132

Brief Summary

studying the antibacterial effect of Cosuts paste as an intracanal medication against Enterococcus faecalis that present in necrotic primary teeth

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
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2021

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

August 19, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

December 10, 2022

Last Update Submit

December 10, 2022

Conditions

Infection Primary

Keywords

infected primary molars, metapaste, herbal paste

Outcome Measures

Primary Outcomes (1)

  • Bacterial count

    Colony forming unit

    1 weak

Study Arms (2)

Costus paste

EXPERIMENTAL

Costus paste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar

Drug: herbal intracanal medication paste

metapaste

ACTIVE COMPARATOR

metapaste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar

Drug: Meta paste

Interventions

herbal intracanal medication pasteDRUG

study the effect of costus herbal paste on enterococcus faecalis bacteria

Also known as: herbal paste
Costus paste
Meta pasteDRUG

compare the effect of Costus paste with meta paste in reducing the number of enterococcus faecalis

Also known as: control paste
metapaste

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients with clinically and radiologically diagnosed infected primary teeth in their mandibular arch.
  • Teeth should be deeply carious, with a history of spontaneous pain and carious exposures with necrotic pulp was also be selected
  • radiographic evidence of adequate alveolar bone support, and absence of internal or external resorption.
  • tooth must be restorable.

You may not qualify if:

  • vital tooth
  • Non restorable teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NUB University

Cairo, Bani Suif, Egypt

RECRUITING

Study Officials

  • Ghada Salem, Ph.D

    associate professor of Pediatric Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada Salem, Ph.D

CONTACT

+201005144561ghadamohamedalirana@hotmail.com

Mariem Elmansy

CONTACT

01223355029drmaryamelmansy@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatric Dentistry

Study Record Dates

First Submitted

December 10, 2022

First Posted

December 20, 2022

Study Start

August 19, 2021

Primary Completion

December 10, 2022

Study Completion

December 30, 2022

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

not to share IPD until publication

Locations

EG(1)