Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication

Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication in Necrotic Primary Molars, a Randomized Control Trial

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

Study Overview

• Status: Recruiting
• Conditions: Infection Primary
• Intervention / Treatment: Drug: herbal intracanal medication paste; Drug: Meta paste

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ghada Salem, Ph.D; Phone Number: +201005144561; Email: ghadamohamedalirana@hotmail.com
• Study Contact Backup: Name: Mariem Elmansy; Phone Number: 01223355029; Email: drmaryamelmansy@hotmail.com

Study Locations

• Egypt
  • Bani Suif
    • Cairo, Bani Suif, Egypt
      • Recruiting
      • NUB University
      • Contact: Ghada Salem, Ph.D; Phone Number: +201005144561; Email: ghadamohamedalirana@hotmail.com
      • Contact: Mariem Elmansy; Phone Number: 01223355029; Email: drmaryamelmansy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; study the effect of costus herbal paste on enterococcus faecalis bacteria; Other Names: herbal 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; compare the effect of Costus paste with meta paste in reducing the number of enterococcus faecalis; Other Names: control paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial count	Colony forming unit	1 weak

Collaborators and Investigators

• Sponsor: Nahda University
• Investigators: Principal Investigator: Ghada Salem, Ph.D, associate professor of Pediatric Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Anticipated): December 10, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: December 10, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: infected primary molars, metapaste, herbal paste
• Other Study ID Numbers: 050622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: not to share IPD until publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No