Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication

NCT ID: NCT05657132

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infection Primary

Keywords

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infected primary molars, metapaste, herbal paste

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
blinded

Study Groups

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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

Group Type EXPERIMENTAL

herbal intracanal medication paste

Intervention Type DRUG

study the effect of costus herbal paste on enterococcus faecalis bacteria

metapaste

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

Group Type ACTIVE_COMPARATOR

Meta paste

Intervention Type DRUG

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

Interventions

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herbal intracanal medication paste

study the effect of costus herbal paste on enterococcus faecalis bacteria

Intervention Type DRUG

Meta paste

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

Intervention Type DRUG

Other Intervention Names

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herbal paste control paste

Eligibility Criteria

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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

* vital tooth
* Non restorable teeth
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nahda University

OTHER

Sponsor Role lead

Responsible Party

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GHada Abdelwahab Ahmed

Associate Professor of Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghada Salem, Ph.D

Role: PRINCIPAL_INVESTIGATOR

associate professor of Pediatric Dentistry

Locations

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NUB University

Cairo, Bani Suif, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ghada Salem, Ph.D

Role: CONTACT

Phone: +201005144561

Email: [email protected]

Mariem Elmansy

Role: CONTACT

Phone: 01223355029

Email: [email protected]

Facility Contacts

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Ghada Salem, Ph.D

Role: primary

Mariem Elmansy

Role: backup

Other Identifiers

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050622

Identifier Type: -

Identifier Source: org_study_id