Plaque ScoreNCT07309679
Effectiveness of Herbal vs Chlorhexidine Mouthwashes in Improving Oral Health in Schoolchildren
A study testing Chlorhexidine Digluconate 0.2% Mouthwash, Pomegranate Peel Extract Mouthwash and Neem Extract Mouthwash in people with Plaque Score and Gingival Health, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Score, Gingival Health, Streptococcus Mutans
- What is being tested?
- Chlorhexidine Digluconate 0.2% Mouthwash, Pomegranate Peel Extract Mouthwash and Neem Extract Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2023to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry,Mansoura university
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: The Effectivness of Two Herbal Mouth-washes Versus Chlorohexidine on Oral Health Among A Group of School Children
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.
Read the detailed 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.
- Conditions
- Plaque Score, Gingival Health, Streptococcus Mutans
- Being tested
- Chlorhexidine Digluconate 0.2% Mouthwash, Pomegranate Peel Extract Mouthwash, Neem Extract Mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Digluconate 0.2% MouthwashDrug
Also called CHX, 0.2% CHX Mouthrinse
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.
Pomegranate Peel Extract MouthwashDrug
Also called PPE Mouthwash, Punica granatum 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
Neem Extract MouthwashDrug
Also called Azadirachta indica Mouthrinse, Neem Herbal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Drug: Neem Extract Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (Silness & Löe)
Outcome measure: Mean change in Plaque Index score (Silness \& Löe) from baseline to 3 weeks.
Measured: baseline , 1 week , 2 weeks, 3 weeks
Gingival Index (Löe & Silness)
Mean change in Gingival Index score (Löe \& Silness) from baseline to 3 weeks.
Measured: baseline , 1 week , 2 weeks, 3 weeks
Salivary Streptococcus mutans Level
Change in salivary Streptococcus mutans count (CFU/ml) from baseline to 3 weeks
Measured: Baseline and 3 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start7 Mar 2023
- Primary completion7 Jun 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque ScoreStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabab I Salama, professor, Principal investigator, Faculty of Dentistry,Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309679
- Sponsor's protocol ID
- A04060922
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared because the study involves children and contains sensitive health information.only aggregated results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivness of Two Herbal Mouth-washes Versus Chlorohexidine on Oral Health Among A Group of School Children
- ClinicalTrials.gov ID
- NCT07309679
- Acronym / sponsor ID
- A04060922
- Conditions
- Plaque Score, Gingival Health, Streptococcus Mutans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Mouthwash Group | Active comparator | Drug: Chlorhexidine Digluconate 0.2% MouthwashParticipants 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 |
| Pomegranate Peel Extract Mouthwash Group | Experimental | Drug: Pomegranate Peel Extract MouthwashParticipants 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. |
| Neem Extract Mouthwash Group | Experimental | Drug: Neem Extract MouthwashParticipants 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine Digluconate 0.2% MouthwashAlso: CHX, 0.2% CHX MouthrinseCommercially 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 | Chlorhexidine Mouthwash Group |
| Pomegranate Peel Extract MouthwashAlso: PPE Mouthwash, Punica granatum MouthrinseMouthwash 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 | Pomegranate Peel Extract Mouthwash Group |
| Neem Extract MouthwashAlso: Azadirachta indica Mouthrinse, Neem Herbal MouthwashMouthwash 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. | Drug | Neem Extract Mouthwash Group |
Primary outcome
Plaque Index (Silness & Löe)
Time frame: baseline , 1 week , 2 weeks, 3 weeks
Outcome measure: Mean change in Plaque Index score (Silness \& Löe) from baseline to 3 weeks.
Gingival Index (Löe & Silness)
Time frame: baseline , 1 week , 2 weeks, 3 weeks
Mean change in Gingival Index score (Löe \& Silness) from baseline to 3 weeks.
Salivary Streptococcus mutans Level
Time frame: Baseline and 3 weeks after start of intervention
Change in salivary Streptococcus mutans count (CFU/ml) from baseline to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabab I Salama, professor principal investigator
Faculty of Dentistry,Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Digluconate 0.2% Mouthwash, Pomegranate Peel Extract Mouthwash and Neem Extract Mouthwash in people with Plaque Score and Gingival Health, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (Silness & Löe) (time frame: baseline , 1 week , 2 weeks, 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.