CClinicalTrials.gg
Active, not recruitingNCT06511336Updated Jul 19, 2024

Alkaline Water and Salivary Bacterial Count

A Phase 3 interventional study of Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt in Dental Caries, sponsored by Pharos University in Alexandria. Active, not recruiting at 1 site in Egypt. Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Pharos University in Alexandria · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

Oral health has a major influence on one's general and oral health-related quality of life and well-being. Dental caries is characterized by demineralization of calcified tissues of the teeth due to several factors. Approximately, 60-65% of children in India are affected by dental caries. Several organisms are involved in the development of carious lesions. However, the literature strongly reports Streptococcus mutans (S. mutans) as the potential organism involved in the initiation of dental caries. This is because S. mutans can attach to the enamel surface, produce acid metabolites, provide glycogen reserves, and can synthesize extracellular polysaccharides.

Several antimicrobial agents with varying efficacy have been reported for the reduction of dental caries. Preventive programs such as the use of fluoride toothpaste, community water fluoridation, and mouth rinses, focusing primarily on the reduction of caries have also been carried out to reduce the prevalence of the disease. These substances inhibit the adhesion of bacteria, their colonization, and metabolic activity ultimately affecting their growth. Presently, bisbiguanide being the most efficacious chemotherapeutic agent against S. mutans has high bactericidal activity against both gram-positive and gram-negative bacteria. But it has a few side effects such as tooth discoloration, the altered sensation of taste, and erosion of oral mucosa. Also, due to the developing antimicrobial resistance to the currently available antibiotics and chemotherapeutics, the implementation of alternative treatment options for oral diseases that are safer, effective, and economical are needed.

Among various natural alternatives which have been studied, alkaline water has gained great interest in dentistry. alkaline water can be a safer and cheaper alternative to chemical adjuncts. The use of mouthwash is quite widespread by the public because the mouthwash is sold freely in stores, supermarkets, or supermarkets, the public only knows the effects of mouthwash to prevent bad breath alone, without knowing the side effects when using for a long time. Based on the problem, the researcher is interested to know whether the alkaline solution has a function like the function of mouthwash that can inhibit streptococcus mutans Materials and Methods this double-blinded randomized control clinical study will be carried out at Pedodontic clinics in Pharos University. A total of 30 schoolchildren will be selected by convenience sampling method. Inclusion criteria involved children between 10 and 12 years of age without any systemic disorder, or presence of gingivitis-calculus.

Exclusion criteria involved children who were already using mouthwashes, history of oral prophylaxis within 6 months, and had fixed or removable orthodontic appliances or removable prostheses. Written informed consent will be obtained from parents of all selected children. The children will be randomly divided into 3 groups by computer-generated random sequence: Group A - alkaline water group, Group B - 0.2% CHX mouthwash group, and Group C - Tap water group. The bottles will be coded along with the written instructions to use before dispensing to the children. The coding was will be done by a person who was not involved in the study; so that the double blinding design of the study was maintained. The children will be provided with 140 ml of their respective mouthwashes for home use every week. The children and examiner will be blind to allocation, i.e., the type of mouthwash. All the selected children were demonstrated a correct method of using mouthwash according to the group that they were assigned to. Children were instructed to use 10 ml of mouthwash as prescribed (i.e., take 10 ml of the mouth rinse in the measuring cap, rinse for 30 s, and spit out twice daily for 21 days), under the parent's supervision. A printed timetable for 3 weeks will be given to the parents, and they were asked to put a checkmark on the form after rinsing to check the compliance of the instructions given. The bacterial count will be evaluated at baseline, week 1, week 2, and week 3

Statistical analysis:

Data will be tabulated and analyzed using SPSS software version 25

02

Conditions studied

  • Dental Caries

Browse trials for

Keywords

  • streptococcus mutans
  • chlorohexidine
  • Alkaline water
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Pharos University in Alexandria is the lead sponsor of 21 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • children aged 10-12 years

Exclusion criteria

Exclusion Criteria:

  • Children wearing orthodontic appliances.
  • suffering from systemic diseases, and taking corticosteroids.
  • taking antibiotics for at least one month
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

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

    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

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

    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

  • Placebo comparator
    children using tap water as mouthwash

    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

  • DrugAlkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt

    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

06

What researchers measure

Primary outcomes

  1. Salivary streptococcus mutans count

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

    Time frame: 3 weeks

07

Study locations

1 site
  • Pharos University in Alexandria
    Alexandria, 536733, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511336
Lead sponsor
Pharos University in Alexandria
Responsible party
Inas Karawia (Lecturer at Pediatric and Community Dentistry Department, Faculty of Dentistry, Pharos University in Alexandria) — Principal investigator
First posted
Jul 19, 2024
Start date
Jul 1, 2024
Primary completion
Aug 10, 2024 (estimated)
Completion
Aug 15, 2024 (estimated)
Last update
Jul 19, 2024

Study contacts

Inas M Karawia
principal investigator · Pharos University in Alexandria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion