ClinicalTrials.gg
Status unknownNCT05657132Updated Dec 20, 2022

Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication

A Phase 3 interventional study of herbal intracanal medication paste and Meta paste in Infection Primary, sponsored by Nahda University. Status unknown at 1 site in Egypt. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Nahda University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Aug 2021, registered Dec 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study summary

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

Read the detailed description

The children were randomly divided into two groups (I, II) Group I (N=12): using Costus-based paste as an intracanal medicament. Group II (N= 12): Calcium hydroxide iodoform paste (Metapex) as an intracanal medicament.

Procedure:

Access opening was started. then a swab was taken from the distal root canal with a dry paper point and transferred to a sterile test tube. The canals were filled with an intracanal medication according to the patient group. In group I, the canals was filled with a previously prepared Costus-based paste for one week, and In Group II, the canals were filled with Meta paste for one week. After 1 week, the paste was washed away from the canals then another swab was taken from the distal canal by a dry paper point as done before preoperatively.

The 2 swabs were transferred within 2 hours to the lab for bacterial culture and detection of enterococcus faecalis count.

02

Conditions studied

  • Infection Primary

Keywords

  • infected primary molars, metapaste, herbal paste
03

In context

Lead sponsor

Nahda University is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • vital tooth
  • Non restorable teeth
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Costus paste

    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

  • Active comparator
    metapaste

    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

  • Drugherbal intracanal medication paste

    study the effect of costus herbal paste on enterococcus faecalis bacteria

    Also known as: herbal paste

  • DrugMeta paste

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

    Also known as: control paste

06

What researchers measure

Primary outcomes

  1. Bacterial count

    Colony forming unit

    Time frame: 1 weak

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — not to share IPD until publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05657132
Lead sponsor
Nahda University
Responsible party
GHada Abdelwahab Ahmed (Associate Professor of Pediatric Dentistry, Nahda University) — Principal investigator
First posted
Dec 20, 2022
Start date
Aug 19, 2021
Primary completion
Dec 10, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Dec 20, 2022

Study contacts

Ghada Salem, Ph.D
Contact
ghadamohamedalirana@hotmail.com
+201005144561
Mariem Elmansy
Contact
drmaryamelmansy@hotmail.com
01223355029
Ghada Salem, Ph.D
principal investigator · associate professor of Pediatric Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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