Effectiveness of Herbal vs Chlorhexidine Mouthwashes in Improving Oral Health in Schoolchildren

NCT07309679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-01-09

No results posted yet for this study

Summary

Dental plaque and gingivitis are common oral health problems among school children. Mechanical plaque control, such as tooth brushing, is essential but may be insufficient for maintaining optimal oral hygiene. Chlorhexidine mouthwash is considered the gold standard chemical plaque control agent; however, its long-term use is limited by side effects such as tooth staining and taste alteration. In recent years, herbal mouthwashes have gained attention as natural alternatives with fewer adverse effects.

This randomized, single-blinded clinical trial was conducted to evaluate the effectiveness of two herbal mouthwashes - pomegranate peel extract and neem extract - compared with 0.2% chlorhexidine mouthwash on oral health among school children aged 8-12 years in Mansoura City, Egypt. A total of 156 participants were divided into three groups based on the type of mouthwash used. Plaque index, gingival index, and salivary Streptococcus mutans levels were assessed at baseline and after three weeks.

The study aimed to determine whether herbal mouthwashes could provide comparable benefits to chlorhexidine in reducing plaque, gingivitis, and bacterial load, while offering better safety and compliance in children.

Conditions

  • Plaque Score
  • Gingival Health
  • Streptococcus Mutans

Interventions

DRUG

Chlorhexidine Digluconate 0.2% Mouthwash

Commercially available 0.2% chlorhexidine digluconate mouthwash used as the gold standard control. Participants rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. Used to compare the antimicrobial and anti-plaque effectiveness against herbal mouthwashes.

DRUG

Pomegranate Peel Extract Mouthwash

Mouthwash containing pomegranate peel extract (Punica granatum Linn.), prepared at Nanogate company. Participants rinsed with 5 ml twice daily for 30 seconds for three weeks under parental supervision. The intervention aimed to evaluate pomegranate's natural anti-inflammatory and antimicrobial effects on plaque, gingivitis, and Streptococcus mutans levels

DRUG

Neem Extract Mouthwash

Mouthwash containing neem extract (Azadirachta indica), prepared at Nanogate company. Participants rinsed with 5 ml twice daily for 30 seconds for three weeks under parental supervision. The intervention was designed to assess neem's antibacterial and plaque-reducing properties compared with chlorhexidine and pomegranate mouthwashes.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Rabab I Salama, professor · Faculty of Dentistry,Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2023-06-07
Completion
2023-11-07

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309679 on ClinicalTrials.gov