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

NCT07309679 | Completed

• 1 other identifier: A04060922
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Plaque Index (Silness & Löe)

  Outcome measure: Mean change in Plaque Index score (Silness \& Löe) from baseline to 3 weeks.

  baseline , 1 week , 2 weeks, 3 weeks

• Gingival Index (Löe & Silness)

  Mean change in Gingival Index score (Löe \& Silness) from baseline to 3 weeks.

  baseline , 1 week , 2 weeks, 3 weeks

• Salivary Streptococcus mutans Level

  Change in salivary Streptococcus mutans count (CFU/ml) from baseline to 3 weeks

  Baseline and 3 weeks after start of intervention

Study Arms (3)

Chlorhexidine Mouthwash Group

ACTIVE COMPARATOR

Participants used 0.2% chlorhexidine mouthwash . Each child rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. This group served as the gold-standard control for evaluating the efficacy of herbal mouthwashes

Drug: Chlorhexidine Digluconate 0.2% Mouthwash

Pomegranate Peel Extract Mouthwash Group

EXPERIMENTAL

Participants used a pomegranate peel extract (Punica granatum Linn.) mouthwash, prepared at Nanogate company. Each child rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. The purpose was to evaluate its natural antimicrobial and anti-gingivitis effects compared to chlorhexidine.

Drug: Pomegranate Peel Extract Mouthwash

Neem Extract Mouthwash Group

EXPERIMENTAL

Participants used a neem (Azadirachta indica) extract mouthwash, prepared at Nanogate company. Each child rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. This group was designed to assess neem's potential antimicrobial and plaque-reducing effects relative to chlorhexidine and pomegranate mouthwashes.

Drug: Neem Extract Mouthwash

Interventions

Neem Extract Mouthwash DRUG

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.

Also known as: Azadirachta indica Mouthrinse, Neem Herbal Mouthwash

Neem Extract Mouthwash Group

Chlorhexidine Digluconate 0.2% Mouthwash DRUG

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.

Also known as: CHX, 0.2% CHX Mouthrinse

Chlorhexidine Mouthwash Group

Pomegranate Peel Extract Mouthwash DRUG

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

Also known as: PPE Mouthwash, Punica granatum Mouthrinse

Pomegranate Peel Extract Mouthwash Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 8 to 12 years (common age group for gingivitis).
• Both male and female participants.
• Plaque Index ≥ 1 according to Silness and Löe index.
• Regular brushing habit (once per day).
• Parental consent obtained prior to participation.

You may not qualify if:

• Children with systemic diseases or conditions affecting salivary flow.
• Children with a history of antibiotic use within the last month before the study.
• Those with known allergy or intolerance to any mouthwash ingredients.
• Children currently using any other mouthwash or oral antiseptic.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry,Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Mouthwashes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rabab I Salama, professor

  Faculty of Dentistry,Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned into three parallel groups, each receiving a different mouthwash: * Group I: Chlorhexidine (0.2%) * Group II: Pomegranate peel extract mouthwash * Group III: Neem extract mouthwash Each participant used only one type of mouthwash for the full 3-week study period. Comparisons were made between groups to evaluate differences in plaque index, gingival index, and salivary Streptococcus mutans levels.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: March 7, 2023
• Primary Completion: June 7, 2023
• Study Completion: November 7, 2023
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)