An interventional study of Chlorhexidine Digluconate 0.2% Mouthwash and Pomegranate Peel Extract Mouthwash in Plaque Score, Gingival Health and Streptococcus Mutans, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
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.
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.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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
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
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
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
Plaque Index (Silness & Löe)
Outcome measure: Mean change in Plaque Index score (Silness \& Löe) from baseline to 3 weeks.
Time frame: baseline , 1 week , 2 weeks, 3 weeks
Gingival Index (Löe & Silness)
Mean change in Gingival Index score (Löe \& Silness) from baseline to 3 weeks.
Time frame: baseline , 1 week , 2 weeks, 3 weeks
Salivary Streptococcus mutans Level
Change in salivary Streptococcus mutans count (CFU/ml) from baseline to 3 weeks
Time frame: Baseline and 3 weeks after start of intervention
Plan to share: No — individual participant data will not be shared because the study involves children and contains sensitive health information.only aggregated results will be published.
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Mansoura University