Antibacterial Effect of Ozonated Olive Oil, Propolis and Chlorhexidine Mouthwashes in Pediatric Patients
Evaluation of the Antibacterial Effect of Ozonated Olive Oil, Propolis, and Chlorhexidine Mouthwashes in Pediatric Patients: A Randomized Controlled Clinical Trial
1 other identifier
interventional
51
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2025
CompletedFirst Submitted
Initial submission to the registry
September 21, 2025
CompletedFirst Posted
Study publicly available on registry
September 29, 2025
CompletedSeptember 29, 2025
September 1, 2025
2 months
September 21, 2025
September 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
Baseline and after 14 days of treatment
Study Arms (3)
Ozonated olive oil mouthwash
EXPERIMENTALPropolis mouthwash
EXPERIMENTALChlorhexidine mouthwash
ACTIVE COMPARATORInterventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, Alexandria University, Egypt
Alexandria, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2025
First Posted
September 29, 2025
Study Start
February 25, 2025
Primary Completion
May 10, 2025
Study Completion
May 10, 2025
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share