Early Childhood Caries (ECC)NCT07245433
Evaluating the Effect of Xylitol Wipes on Cariogenic Bacteria in Infants and Toddlers
A study testing Xylitol Dental Wipes in people with Early Childhood Caries (ECC) and Dental Caries Prevention, run by Alexandria University at 1 site in Egypt.
Trial summary
This clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral bacteria associated with early childhood caries. A total of 20 healthy children aged 9 to 18 months are enrolled. Read more about this study
- Who is it for?
- Ages 9 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries (ECC), Dental Caries Prevention, Oral Bacterial Colonization
- What is being tested?
- Xylitol Dental Wipes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Nov 2025
- Phase
- Interventional
- 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 9 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants and toddlers aged 9 months to 18 months
- Caries-free (no visible dental decay or white spot lesions)
- Cooperative child and mother willing to participate for 4 weeks
- Mother able to understand and follow instructions for xylitol wipe use
- Written informed consent obtained from parent or legal guardian
Who cannot join
- Infants or toddlers with systemic diseases or medical conditions affecting saliva
- Use of antibiotics or antimicrobial mouth products within the past 4 weeks
- Known allergy or sensitivity to xylitol or product components
- Existing oral lesions or ongoing dental treatment
- Non-compliance with study protocol or loss to follow-up
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Egypt, 21521
About this study
Official title: Evaluating the Effect of Xylitol Wipes on Cariogenic Bacteria in Infants and Toddlers: A Longitudinal Clinical Trial
This clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral bacteria associated with early childhood caries. A total of 20 healthy children aged 9 to 18 months are enrolled. Mothers are instructed to clean their children's teeth and gums using xylitol dental wipes three times daily after meals for four weeks. Saliva samples are collected at baseline and during weekly follow-up visits to measure lactic acid levels and mutans streptococci counts. A pediatric dentist examines each child at every visit to monitor general oral health and to check for any potential side effects. The study aims to assess the feasibility, safety, and potential preventive value of parent-applied xylitol wipes during early childhood.
Read the detailed description
This longitudinal interventional study is designed to assess the preventive effect of xylitol-containing dental wipes on oral bacteria linked to early childhood caries (ECC). The study enrolls 20 healthy, caries-free infants and toddlers aged 9 to 18 months attending the Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University. After obtaining informed consent, mothers are instructed to use commercially available xylitol dental wipes (Spiffies Baby Tooth Wipes™, Dr. Products Inc., USA) to clean their children's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contains a xylitol-based solution intended to provide mechanical cleaning and daily exposure to approximately 4.2 g of xylitol.
Saliva samples are collected at baseline and at four weekly follow-up visits. Two primary outcome measures are assessed:
Lactic acid levels, using the Clinpro Cario-L-Pop chairside kit (3M ESPE, Germany) Mutans streptococci counts, using the CRT Bacteria Caries Risk Test (Ivoclar Vivadent, Liechtenstein) Participants are monitored weekly to assess compliance, document any dietary changes, and report potential side effects, including mild gastrointestinal symptoms. Children undergo oral examinations by a pediatric dentist at each visit to evaluate oral tissues and overall tolerance of the intervention.
The study protocol focuses on determining whether the regular use of xylitol wipes is feasible, acceptable to parents and children, and potentially useful as a preventive measure against early childhood oral bacterial activity.
- Conditions
- Early Childhood Caries (ECC), Dental Caries Prevention, Oral Bacterial Colonization, Pediatric Oral Health
- Being tested
- Xylitol Dental Wipes
- Keywords
- xylitol wipes, mutans streptococci, lactic acid, early childhood caries, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol Dental WipesOther
Commercially available xylitol dental wipes were used for daily oral cleaning in infants and toddlers. Mothers were instructed to wipe their child's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contained a xylitol-based solution providing a total daily exposure of approximately 4.2 g of xylitol. The intervention aimed to reduce cariogenic bacterial activity and prevent early childhood caries. Compliance, tolerance, and any minor side effects were recorded weekly during follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Xylitol Wipe Intervention | Experimental | All participants (children aged 9-18 months) in this single-arm study received the same intervention. Mothers were instructed to use commercially available xylitol dental wipes to clean their child's teeth and gums three times daily after meals for four weeks. Each wipe provided an estimated total daily xylitol exposure of about 4.2 g.
The purpose of the intervention was to evaluate its preventive effect on early childhood caries by reducing cariogenic bacterial activity. The primary outcomes measured were:
Salivary lactic acid levels using the Clinpro Cario-L-Pop chairside test kit. Mutans streptococci counts using the CRT bacteria caries risk test. All children were monitored weekly for compliance, oral health status, and any minor side effects. No comparator or placebo arm was included. Receives: Other: Xylitol Dental Wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary lactic acid level
Description: Lactic acid level in saliva measured using the Clinpro Cario-L-Pop chairside kit.
Unit of Measure: Lactic acid score (1-9 scale).
Measured: Baseline; weeks 1, 2, 3, and 4.
Change in salivary mutans streptococci (MS) count
Description: Mutans streptococci colony density assessed using the CRT bacteria caries risk test.
Unit of Measure: MS score (0-3 scale).
Measured: Baseline; weeks 1, 2, 3, and 4.
Secondary outcomes (1)
Parental compliance and tolerance to xylitol wipes
Description: Compliance is assessed by the number of wipes used per day, as reported by mothers during weekly interviews. During the same visits, mothers are asked whether any minor side effects (such as gastrointestinal discomfort or irritation) occurred in the child; these observations are recorded for monitoring purposes but are not treated as separate outcome variables.
Unit of Measure: Number of wipes used per day.
Measured: Weekly for 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Early Childhood Caries (ECC)Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, before-after longitudinal design. All enrolled children (9 months to 1.5 years) received the same intervention: mothers used commercially available xylitol dental wipes for their child 3 times daily for 4 weeks (4.2g/day). Outcomes (salivary lactic acid via Clinpro Cario-L-Pop and mutans streptococci counts via CRT kit) were measured at baseline and weekly for 4 visits. Compliance and adverse events were checked at each visit. No randomization or masking.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abdelsadek, BDS, MSc, PhD, Alexandria University
- Investigators
- Omar A El Meligy, BDS,MSc,PhD, Principal investigator, Alexandria UniversityLaila M El-Habashy, BDS,MSc,PhD, Principal investigator, Alexandria University and Pharos UniversityAliaa A Hamouda, BDS,MSc,PhD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245433
- Sponsor's protocol ID
- Faculty of Dentistry
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not or might not be shared due to the small sample size and privacy concerns involving infant participants.
Publications
Babu V, Hegde S, Bhat S, Sargod S. Evaluation of Efficacy of Three Different Commercially Available Kit for Chairside Cariogenic Bacteria Test - Caries Risk Test, Saliva-check Mutans and CariScreen. Cureus. 2019 Dec 29;11(12):e6504. doi: 10.7759/cureus.6504.
PubMed 32025425Galganny-Almeida A, Queiroz MC, Leite AJ. The effectiveness of a novel infant tooth wipe in high caries-risk babies 8 to15 months old. Pediatr Dent. 2007 Jul-Aug;29(4):337-42.
PubMed 17867402Soderling E, Pienihakkinen K. Specific effects of xylitol chewing gum on mutans streptococci levels, plaque accumulation and caries occurrence: a systematic review. BMC Oral Health. 2025 Jul 29;25(1):1275. doi: 10.1186/s12903-025-06602-1.
PubMed 40731400Soderling EM. Xylitol, mutans streptococci, and dental plaque. Adv Dent Res. 2009;21(1):74-8. doi: 10.1177/0895937409335642. No abstract available.
PubMed 19717413Miyasawa-Hori H, Aizawa S, Takahashi N. Difference in the xylitol sensitivity of acid production among Streptococcus mutans strains and the biochemical mechanism. Oral Microbiol Immunol. 2006 Aug;21(4):201-5. doi: 10.1111/j.1399-302X.2006.00273.x.
PubMed 16842502Kishi M, Abe A, Kishi K, Ohara-Nemoto Y, Kimura S, Yonemitsu M. Relationship of quantitative salivary levels of Streptococcus mutans and S. sobrinus in mothers to caries status and colonization of mutans streptococci in plaque in their 2.5-year-old children. Community Dent Oral Epidemiol. 2009 Jun;37(3):241-9. doi: 10.1111/j.1600-0528.2009.00472.x.
PubMed 19508271El-Habashy LM, El Meligy OAES, Hamouda AA. Evaluating the effect of xylitol wipes on cariogenic bacteria in infants and toddlers: a longitudinal clinical trial. BMC Oral Health. 2026 Mar 27;26(1):631. doi: 10.1186/s12903-026-08018-x.
PubMed 41888802
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Xylitol Wipes on Cariogenic Bacteria in Infants and Toddlers: A Longitudinal Clinical Trial
- ClinicalTrials.gov ID
- NCT07245433
- Acronym / sponsor ID
- Faculty of Dentistry
- Conditions
- Early Childhood Caries (ECC), Dental Caries Prevention, Oral Bacterial Colonization, Pediatric Oral Health
- Keywords
- xylitol wipes, mutans streptococci, lactic acid, early childhood caries, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 24 Nov 2025 (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 clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral bacteria associated with early childhood caries. A total of 20 healthy children aged 9 to 18 months are enrolled. Mothers are instructed to clean their children's teeth and gums using xylitol dental wipes three times daily after meals for four weeks. Saliva samples are collected at baseline and during weekly follow-up visits to measure lactic acid levels and mutans streptococci counts. A pediatric dentist examines each child at every visit to monitor general oral health and to check for any potential side effects. The study aims to assess the feasibility, safety, and potential preventive value of parent-applied xylitol wipes during early childhood.
Detailed description
This longitudinal interventional study is designed to assess the preventive effect of xylitol-containing dental wipes on oral bacteria linked to early childhood caries (ECC). The study enrolls 20 healthy, caries-free infants and toddlers aged 9 to 18 months attending the Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University. After obtaining informed consent, mothers are instructed to use commercially available xylitol dental wipes (Spiffies Baby Tooth Wipes™, Dr. Products Inc., USA) to clean their children's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contains a xylitol-based solution intended to provide mechanical cleaning and daily exposure to approximately 4.2 g of xylitol.
Saliva samples are collected at baseline and at four weekly follow-up visits. Two primary outcome measures are assessed:
Lactic acid levels, using the Clinpro Cario-L-Pop chairside kit (3M ESPE, Germany) Mutans streptococci counts, using the CRT Bacteria Caries Risk Test (Ivoclar Vivadent, Liechtenstein) Participants are monitored weekly to assess compliance, document any dietary changes, and report potential side effects, including mild gastrointestinal symptoms. Children undergo oral examinations by a pediatric dentist at each visit to evaluate oral tissues and overall tolerance of the intervention.
The study protocol focuses on determining whether the regular use of xylitol wipes is feasible, acceptable to parents and children, and potentially useful as a preventive measure against early childhood oral bacterial activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, before-after longitudinal design. All enrolled children (9 months to 1.5 years) received the same intervention: mothers used commercially available xylitol dental wipes for their child 3 times daily for 4 weeks (4.2g/day). Outcomes (salivary lactic acid via Clinpro Cario-L-Pop and mutans streptococci counts via CRT kit) were measured at baseline and weekly for 4 visits. Compliance and adverse events were checked at each visit. No randomization or masking.
| Arm | Type | Receives |
|---|---|---|
| Xylitol Wipe Intervention | Experimental | Other: Xylitol Dental WipesAll participants (children aged 9-18 months) in this single-arm study received the same intervention. Mothers were instructed to use commercially available xylitol dental wipes to clean their child's teeth and gums three times daily after meals for four weeks. Each wipe provided an estimated total daily xylitol exposure of about 4.2 g. The purpose of the intervention was to evaluate its preventive effect on early childhood caries by reducing cariogenic bacterial activity. The primary outcomes measured were: Salivary lactic acid levels using the Clinpro Cario-L-Pop chairside test kit. Mutans streptococci counts using the CRT bacteria caries risk test. All children were monitored weekly for compliance, oral health status, and any minor side effects. No comparator or placebo arm was included. |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants and toddlers aged 9 months to 18 months
- Caries-free (no visible dental decay or white spot lesions)
- Cooperative child and mother willing to participate for 4 weeks
- Mother able to understand and follow instructions for xylitol wipe use
- Written informed consent obtained from parent or legal guardian
Key exclusion criteria (5 listed)
- Infants or toddlers with systemic diseases or medical conditions affecting saliva
- Use of antibiotics or antimicrobial mouth products within the past 4 weeks
- Known allergy or sensitivity to xylitol or product components
- Existing oral lesions or ongoing dental treatment
- Non-compliance with study protocol or loss to follow-up
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 |
|---|---|---|
| Xylitol Dental WipesCommercially available xylitol dental wipes were used for daily oral cleaning in infants and toddlers. Mothers were instructed to wipe their child's teeth and gums three times daily after meals for four consecutive weeks. Each wipe contained a xylitol-based solution providing a total daily exposure of approximately 4.2 g of xylitol. The intervention aimed to reduce cariogenic bacterial activity and prevent early childhood caries. Compliance, tolerance, and any minor side effects were recorded weekly during follow-up visits. | Other | Xylitol Wipe Intervention |
Primary outcome
Change in salivary lactic acid level
Time frame: Baseline; weeks 1, 2, 3, and 4.
Description: Lactic acid level in saliva measured using the Clinpro Cario-L-Pop chairside kit. Unit of Measure: Lactic acid score (1-9 scale).
Change in salivary mutans streptococci (MS) count
Time frame: Baseline; weeks 1, 2, 3, and 4.
Description: Mutans streptococci colony density assessed using the CRT bacteria caries risk test. Unit of Measure: MS score (0-3 scale).
1 secondary outcome
Parental compliance and tolerance to xylitol wipes
Time frame: Weekly for 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication: PubMed 32025425Babu V, Hegde S, Bhat S, Sargod S. Evaluation of Efficacy of Three Different Commercially Available Kit for Chairside Cariogenic Bacteria Test - Caries Risk Test, Saliva-check Mutans and CariScreen. Cureus. 2019 Dec 29;11(12):e6504. doi: 10.7759/cureus.6504.
- Results publication: PubMed 17867402Galganny-Almeida A, Queiroz MC, Leite AJ. The effectiveness of a novel infant tooth wipe in high caries-risk babies 8 to15 months old. Pediatr Dent. 2007 Jul-Aug;29(4):337-42.
- Results publication: PubMed 40731400Soderling E, Pienihakkinen K. Specific effects of xylitol chewing gum on mutans streptococci levels, plaque accumulation and caries occurrence: a systematic review. BMC Oral Health. 2025 Jul 29;25(1):1275. doi: 10.1186/s12903-025-06602-1.
- Results publication: PubMed 19717413Soderling EM. Xylitol, mutans streptococci, and dental plaque. Adv Dent Res. 2009;21(1):74-8. doi: 10.1177/0895937409335642. No abstract available.
- Results publication: PubMed 16842502Miyasawa-Hori H, Aizawa S, Takahashi N. Difference in the xylitol sensitivity of acid production among Streptococcus mutans strains and the biochemical mechanism. Oral Microbiol Immunol. 2006 Aug;21(4):201-5. doi: 10.1111/j.1399-302X.2006.00273.x.
- Results publication: PubMed 19508271Kishi M, Abe A, Kishi K, Ohara-Nemoto Y, Kimura S, Yonemitsu M. Relationship of quantitative salivary levels of Streptococcus mutans and S. sobrinus in mothers to caries status and colonization of mutans streptococci in plaque in their 2.5-year-old children. Community Dent Oral Epidemiol. 2009 Jun;37(3):241-9. doi: 10.1111/j.1600-0528.2009.00472.x.
- Derived from this study: PubMed 41888802El-Habashy LM, El Meligy OAES, Hamouda AA. Evaluating the effect of xylitol wipes on cariogenic bacteria in infants and toddlers: a longitudinal clinical trial. BMC Oral Health. 2026 Mar 27;26(1):631. doi: 10.1186/s12903-026-08018-x.
- Individual participant dataSharing planned: Undecided. Individual participant data will not or might not be shared due to the small sample size and privacy concerns involving infant participants.
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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.
Omar A El Meligy, BDS,MSc,PhD principal investigator
Alexandria University
Laila M El-Habashy, BDS,MSc,PhD principal investigator
Alexandria University and Pharos University
Aliaa A Hamouda, BDS,MSc,PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol Dental Wipes in people with Early Childhood Caries (ECC) and Dental Caries Prevention, run by Alexandria University 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 24 Nov 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in salivary lactic acid level (time frame: Baseline; weeks 1, 2, 3, and 4.). The study lists 2 primary outcomes in all. 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 NCT07245433, which also lists 7 linked publications.
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 24 Nov 2025.