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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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 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 comparator | Children 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 mouthwash | Placebo comparator | Children 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.
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.
- First posted19 Jul 2024
- Study start1 Jul 2024
- Primary completion10 Aug 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inas Karawia, Pharos University in Alexandria
- Investigators
- Inas M Karawia, Principal investigator, Pharos University in Alexandria
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alkaline Water Effect on Salivary Streptococcus Mutans in Children
- ClinicalTrials.gov ID
- NCT06511336
- Acronym / sponsor ID
- UREAC-04-3-222
- Conditions
- Dental Caries
- Keywords
- streptococcus mutans, chlorohexidine, Alkaline water
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children using Alkaline water as mouthwash (FLO- bottled natural drinking water - made in Egypt) | Experimental | Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in EgyptChildren in this group will be asked to use alkaline water as mouthwash once daily for 3 weeks |
| children using chlorohexidine mouthwash (Orovex- MARCO Pharmaceuticals- made in Egypt) | Active comparator | Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in EgyptChildren in this group will be asked to use chlorohexidine as mouthwash once daily for 3 weeks |
| children using tap water as mouthwash | Placebo comparator | Drug: Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in EgyptChildren in this group will be asked to use tap water as mouthwash once daily for 3 weeks |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 10-12 years
Key exclusion criteria (3 listed)
- Children wearing orthodontic appliances.
- suffering from systemic diseases, and taking corticosteroids.
- taking antibiotics for at least one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alkaline water (FLO water- Bottled drinking water- the Egyption Saudi Company for natural water- made in EgyptAlso: Alkaline waterchildren will use Alkaline water as mouthwash daily for 3 weeks. each time they will use 10 ml of their mouthwash for 30 seconds | Drug | 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 |
Primary outcome
Salivary streptococcus mutans count
Time frame: 3 weeks
the count of salivary coccus mutans bacteria which is the main cause of dental cariea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 42310055Karawia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inas M Karawia principal investigator
Pharos University in Alexandria
1 site in 1 country: see every site and its status.
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.