Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children.

NCT07828171 | Active Not Recruiting

• 1 other identifier: 24-029
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial that compares the antibacterial effectiveness of three mouthwashes-licorice, clove, and chlorhexidine-in Egyptian children aged 7-12 years. The main focus is Streptococcus mutans, one of the main bacteria associated with dental caries. The saliva samples will be collected from the children and the amount of S. mutans will be measured before and after using the assigned mouthwash. The children will be randomly divided into groups, with each group receiving one of the three mouthwashes. The bacterial counts will then be compared to determine which mouthwash is most effective at reducing salivary S. mutans. The research question is whether natural mouthwashes made from licorice or clove reduce the bacteria that cause cavities as effectively as chlorhexidine in children? The study could help determine whether licorice and clove are effective natural alternatives or adjuncts to chlorhexidine, particularly considering that chlorhexidine can have undesirable effects with prolonged use. Overall aim: Compare and evaluate the antibacterial efficacy of the three mouthwashes

Conditions

Streptococcal Infections; Mouthwashes; Dental Caries

Outcome Measures

Primary Outcomes (1)

• Reduction of dental caries incidence in high-caries index pediatric patients using International Caries Detection and Assessment System.

  Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.

Secondary Outcomes (3)

• The reduction in Streptococcus mutans count following the use of licorice and clove mouthwashes in Egyptian pediatric patients aged from 7 to 12.

  Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.

• Patient reported satisfaction, regarding the taste using a questionnaire.

  Through study completion, an average of 3 months.

• Adverse events related to the use of the licorice and clove mouthwashes, regarding oral irritation and allergies using a questionnaire.

  Through study completion, an average of 3 months.

Study Arms (3)

Chlorohexidine Mouthwash

ACTIVE COMPARATOR

Other: Mouth wash

Clove mouthwash

EXPERIMENTAL

Other: Mouth wash

Licorice mouthwash

EXPERIMENTAL

Other: Mouth wash

Interventions

Mouth wash OTHER

The interventions will consist of three different mouthwashes: licorice mouthwash, clove mouthwash, and 0.2% chlorhexidine mouthwash. Each participant will use the mouthwash assigned to their study group according to the standardized study protocol. The herbal mouthwashes will be prepared using standardized licorice and clove extracts at predetermined concentrations, while the chlorhexidine group will receive 0.2% chlorhexidine mouthwash as the positive control. All mouthwashes will be provided in identical, appropriately labeled containers to maintain blinding where applicable. The interventions will be distinguished by their active ingredient and concentration, while the method, frequency, duration of use, and volume administered will be standardized across all groups.

Chlorohexidine Mouthwash; Clove mouthwash; Licorice mouthwash

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients with high caries index based on CAMBRA.
• Frankl scale 3 and 4 (cooperative).

You may not qualify if:

• Patients with teeth showing signs of infection (abscess or fistula)
• Patients with mucositis (can't be given alcohol containing mouthwashes)
• Hypertensive patients.
• Allergic patients.
• Special health care patients.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British university in Egypt

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Dental Caries; Streptococcal Infections

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 18, 2026
• Study Start: October 6, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

EG (1)