NCT06511336

Brief Summary

This study will be aimed to examine the effect of alkaline water on salivary streptococcus mutans bacteria which is the main cause of dental caries and comparing its effect with chlorohexidine mouthwash on the children aged 10-12. tap water will be used as mouthwash for negative control group.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 1, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 9, 2024

Last Update Submit

July 15, 2024

Conditions

Dental Caries

Keywords

streptococcus mutanschlorohexidineAlkaline water

Outcome Measures

Primary Outcomes (1)

  • Salivary streptococcus mutans count

    the count of salivary coccus mutans bacteria which is the main cause of dental cariea

    3 weeks

Study Arms (3)

children using Alkaline water as mouthwash (FLO- bottled natural drinking water - made in Egypt)

EXPERIMENTAL

Children in this group will be asked to use alkaline water as mouthwash once daily for 3 weeks

Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt

children using chlorohexidine mouthwash (Orovex- MARCO Pharmaceuticals- made in Egypt)

ACTIVE COMPARATOR

Children in this group will be asked to use chlorohexidine as mouthwash once daily for 3 weeks

Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt

children using tap water as mouthwash

PLACEBO COMPARATOR

Children in this group will be asked to use tap water as mouthwash once daily for 3 weeks

Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt

Interventions

Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in EgyptDRUG

children will use Alkaline water as mouthwash daily for 3 weeks. each time they will use 10 ml of their mouthwash for 30 seconds

Also known as: Alkaline water
children using Alkaline water as mouthwash (FLO- bottled natural drinking water - made in Egypt)children using chlorohexidine mouthwash (Orovex- MARCO Pharmaceuticals- made in Egypt)children using tap water as mouthwash

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged 10-12 years

You may not qualify if:

  • Children wearing orthodontic appliances.
  • suffering from systemic diseases, and taking corticosteroids.
  • taking antibiotics for at least one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharos University in Alexandria

Alexandria, 536733, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Inas M Karawia

    Pharos University in Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Pediatric and Community Dentistry Department, Faculty of Dentistry

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 19, 2024

Study Start

July 1, 2024

Primary Completion

August 10, 2024

Study Completion

August 15, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)