Oral HygieneNCT07197073
Antibacterial Effect of Ozonated Olive Oil, Propolis and Chlorhexidine Mouthwashes in Pediatric Patients
A study testing Ozonated olive oil, Propolis and Chlorhexidine in people with Oral Hygiene and Oral Health, run by Alexandria University at 1 site in Egypt.
Trial summary
Streptococcus mutans and Lactobacillus acidophilus are the most common cariogenic microorganisms. Chlorhexidine has been the most widely used antibacterial mouthwash in dentistry. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Oral Hygiene, Oral Health
- What is being tested?
- Ozonated olive oil, Propolis and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2025to 10 May 2025
- 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
- No healthy volunteers
- Child
Who may be able to join
- High caries risk patients, according to AAPD guidelines, with visible caries or radiographic penetration into dentin, white spots on smooth surfaces, or recent restorations or missing teeth due to caries.
- Cooperative children according to Frankl's rating (score 3 \& 4)
Who cannot join
- Children with any medical illness or oral infection or those who received any type of antibiotic treatment or mouthwash for two weeks before or during the study were excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Evaluation of the Antibacterial Effect of Ozonated Olive Oil, Propolis, and Chlorhexidine Mouthwashes in Pediatric Patients: A Randomized Controlled Clinical Trial
Streptococcus mutans and Lactobacillus acidophilus are the most common cariogenic microorganisms. Chlorhexidine has been the most widely used antibacterial mouthwash in dentistry. On the other hand, few studies have reported the antibacterial potential of Propolis and Ozonated olive oil as antibacterial agents that can be used as alternatives to Chlorhexidine. This study aims to evaluate and compare the antibacterial effect of Ozonated olive oil, Propolis, and Chlorhexidine on S. mutans and L. acidophilus count in pediatric patients.
- Conditions
- Oral Hygiene, Oral Health
- Being tested
- Ozonated olive oil, Propolis, Chlorhexidine
- Keywords
- Ozonated olive oil, Chlorhexidine, Antibacterial, Propolis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated olive oilOther
Ozonated olive oil mouthwash will be prepared by Smart Ozone Marvel using by company's ozone. Children will be instructed to use 10 ml of mouthwash for 1 minute twice daily after 1 hour after tooth brushing
PropolisOther
Propolis mouthwash will be prepared by using 2% raw propolis, 40 ml flavouring and 0.1 gm coloring agents, 150 ml propylene glycol, and 60 gm sorbitol. Children will be instructed to use 10 ml of mouthwash for 1 minute twice daily after 1 hour after tooth brushing
ChlorhexidineOther
The patients were given 0.12% Chlorhexidine. Children will be instructed to use 10 ml of mouthwash for 1 minute twice daily after 1 hour after tooth brushing
| Study group | Role | What they receive |
|---|---|---|
| Ozonated olive oil mouthwash | Experimental | Not described Receives: Other: Ozonated olive oil |
| Propolis mouthwash | Experimental | Not described Receives: Other: Propolis |
| Chlorhexidine mouthwash | Active comparator | Not described Receives: Other: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbial count
Total bacterial count before and after the intervention was detected. plaque samples were dispersed by vortexing for 30 seconds then 10 fold serially diluted using sterile saline.
Measured: Baseline and after 14 days of treatment
Change in plaque accumulation
The plaque accumulation was scored for each tooth on its four surfaces.The number of positively scored surfaces is divided by the total number of tooth surfaces evaluated and the result is multiplied by 100 to express the index as a percentage
Measured: Baseline and after 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start25 Feb 2025
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197073
- Sponsor's protocol ID
- 0937_07/2024
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antibacterial Effect of Ozonated Olive Oil, Propolis, and Chlorhexidine Mouthwashes in Pediatric Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07197073
- Acronym / sponsor ID
- 0937_07/2024
- Conditions
- Oral Hygiene, Oral Health
- Keywords
- Ozonated olive oil, Chlorhexidine, Antibacterial, Propolis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 29 Sep 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.
Streptococcus mutans and Lactobacillus acidophilus are the most common cariogenic microorganisms. Chlorhexidine has been the most widely used antibacterial mouthwash in dentistry. On the other hand, few studies have reported the antibacterial potential of Propolis and Ozonated olive oil as antibacterial agents that can be used as alternatives to Chlorhexidine. This study aims to evaluate and compare the antibacterial effect of Ozonated olive oil, Propolis, and Chlorhexidine on S. mutans and L. acidophilus count in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozonated olive oil mouthwash | Experimental | Other: Ozonated olive oil |
| Propolis mouthwash | Experimental | Other: Propolis |
| Chlorhexidine mouthwash | Active comparator | Other: Chlorhexidine |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- High caries risk patients, according to AAPD guidelines, with visible caries or radiographic penetration into dentin, white spots on smooth surfaces, or recent restorations or missing teeth due to caries.
- Cooperative children according to Frankl's rating (score 3 \& 4)
Key exclusion criteria (1 listed)
- Children with any medical illness or oral infection or those who received any type of antibiotic treatment or mouthwash for two weeks before or during the study were excluded
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 |
|---|---|---|
| Ozonated olive oilOzonated olive oil mouthwash will be prepared by Smart Ozone Marvel using by company's ozone. Children will be instructed to use 10 ml of mouthwash for 1 minute twice daily after 1 hour after tooth brushing | Other | Ozonated olive oil mouthwash |
| PropolisPropolis mouthwash will be prepared by using 2% raw propolis, 40 ml flavouring and 0.1 gm coloring agents, 150 ml propylene glycol, and 60 gm sorbitol. Children will be instructed to use 10 ml of mouthwash for 1 minute twice daily after 1 hour after tooth brushing | Other | Propolis mouthwash |
| ChlorhexidineThe patients were given 0.12% Chlorhexidine. Children will be instructed to use 10 ml of mouthwash for 1 minute twice daily after 1 hour after tooth brushing | Other | Chlorhexidine mouthwash |
Primary outcome
Change in microbial count
Time frame: Baseline and after 14 days of treatment
Total bacterial count before and after the intervention was detected. plaque samples were dispersed by vortexing for 30 seconds then 10 fold serially diluted using sterile saline.
Change in plaque accumulation
Time frame: Baseline and after 14 days of treatment
The plaque accumulation was scored for each tooth on its four surfaces.The number of positively scored surfaces is divided by the total number of tooth surfaces evaluated and the result is multiplied by 100 to express the index as a percentage
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonated olive oil, Propolis and Chlorhexidine in people with Oral Hygiene and Oral Health, run by Alexandria 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 2 inclusion and 1 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 29 Sep 2025. 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?
Change in microbial count (time frame: Baseline and after 14 days of treatment). The study lists 2 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 29 Sep 2025.