NCT07197073

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 21, 2025

Last Update Submit

September 21, 2025

Conditions

Keywords

Ozonated olive oilChlorhexidineAntibacterialPropolis

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

EXPERIMENTAL
Other: Ozonated olive oil

Propolis mouthwash

EXPERIMENTAL
Other: Propolis

Chlorhexidine mouthwash

ACTIVE COMPARATOR
Other: Chlorhexidine

Interventions

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

Ozonated olive oil mouthwash

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

Propolis mouthwash

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

Chlorhexidine mouthwash

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Interventions

PropolisChlorhexidine

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex MixturesBiguanidesGuanidinesAmidinesOrganic Chemicals

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

Locations