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

Mansoura University

Status: Completed

Conditions: Gingival Health; Streptococcus Mutans; Plaque Score

Treatments: Drug: Chlorhexidine Digluconate 0.2% Mouthwash; Drug: Neem Extract Mouthwash; Drug: Pomegranate Peel Extract Mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT07309679

A04060922

Details and patient eligibility

About

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.

Full description

Dental plaque is a biofilm composed of microbial communities that play a central role in the development of gingivitis and dental caries. Gingivitis is one of the most prevalent oral diseases among children, often resulting from the interaction between bacterial accumulation and host factors. Although mechanical plaque control through toothbrushing is the primary preventive measure, its effectiveness depends on manual skill and motivation, especially in children. Chemical plaque control using antimicrobial mouthwashes is therefore recommended as an adjunct.

Chlorhexidine (CHX) is considered the "gold standard" chemical agent for controlling plaque and gingival inflammation due to its broad-spectrum antimicrobial activity and substantivity. However, its long-term use is associated with side effects such as tooth staining, altered taste, and burning sensations, which can affect compliance. These limitations have encouraged the search for natural alternatives with fewer adverse effects and good acceptability, particularly for pediatric use.

This clinical trial evaluated the effectiveness of two herbal mouthwashes-pomegranate peel extract (Punica granatum Linn.) and neem extract (Azadirachta indica)-compared with chlorhexidine 0.2% mouthwash on oral health among school children in Mansoura City, Egypt. A randomized, single-blinded, parallel-group clinical trial design was adopted. A total of 156 children aged 8-12 years with a plaque index ≥1 were included and randomly assigned to one of three groups: Group I (chlorhexidine), Group II (pomegranate peel extract), and Group III (neem extract). Each participant used 5 ml of the assigned mouthwash twice daily for three weeks under parental supervision.

Plaque index (Silness and Löe), gingival index (Löe and Silness), and salivary Streptococcus mutans levels were measured at baseline and after three weeks. Compliance was monitored weekly. Data were analyzed using SPSS version 24 with a significance level of 0.05.

The study aimed to assess whether pomegranate peel and neem mouthwashes could produce plaque, gingival, and microbial reductions comparable to those of chlorhexidine, while providing improved safety and patient acceptability. Findings from this trial are expected to support the potential use of herbal mouthwashes as effective and natural alternatives for maintaining oral hygiene in children.

Enrollment: 156 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 3 patient groups

Chlorhexidine Mouthwash Group

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine Digluconate 0.2% Mouthwash

Pomegranate Peel Extract Mouthwash Group

Experimental group

Description:

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.

Treatment:

Drug: Pomegranate Peel Extract Mouthwash

Neem Extract Mouthwash Group

Experimental group

Description:

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.

Treatment:

Drug: Neem Extract Mouthwash