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Dental CariesPhase 3NCT06511336

Alkaline Water and Salivary Bacterial Count

A Phase 3 study testing Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt in people with Dental Caries, run by Pharos University in Alexandria at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 10 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jul 2024to 15 Aug 2024
Phase
Phase 3
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 10 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • children aged 10-12 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Pharos University in Alexandria

    Alexandria, 536733

Other trials in Egypt

About this study

Official title: Evaluation of Alkaline Water Effect on Salivary Streptococcus Mutans in Children

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

Conditions
Dental Caries
Being tested
Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt
Keywords
streptococcus mutans, chlorohexidine, Alkaline water
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Alkaline water

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

Study groups in NCT06511336
Study groupRoleWhat they receive
children using Alkaline water as mouthwash (FLO- bottled natural drinking water - made in Egypt)ExperimentalChildren in this group will be asked to use alkaline water as mouthwash once daily for 3 weeks
Receives: 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 comparatorChildren in this group will be asked to use chlorohexidine as mouthwash once daily for 3 weeks
Receives: Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt
children using tap water as mouthwashPlacebo comparatorChildren in this group will be asked to use tap water as mouthwash once daily for 3 weeks
Receives: Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary streptococcus mutans count

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

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completion10 Aug 2024 (estimated)
  4. Study completion15 Aug 2024 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511336
Sponsor's protocol ID
UREAC-04-3-222
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karawia I, Hall MA, Elbayoumi MA, Mohamed OS. Evaluation of the alkaline water effect on the salivary bacteria of children: preliminary randomized trial. Sci Rep. 2026 Jun 17;16(1):18863. doi: 10.1038/s41598-026-57377-6.

    PubMed 42310055

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in Egypt in people with Dental Caries, run by Pharos University in Alexandria 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Salivary streptococcus mutans count (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06511336, which also lists 1 linked publication.

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 19 Jul 2024.

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