Trial · NCT04399161
Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk
NCT04399161, Phase 2, Phase 3, Completed, Dr. Krupa NC; results first posted 2020-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk. Trials, record NCT04399161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04399161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anticaries Effect of Xylitol,Probiotic and Chlorhexidine Mouth Rinses Among Individuals at High Risk
- NCT number
- NCT04399161
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Dr. Krupa NC
- Conditions
- Cariostatic Agents, Mouthwashes
- Interventions
- Chlorhexidine mouthwash, Xylitol, Probiotic
- First posted
- 2020-05-22
- Last updated
- 2020-07-22
- Results first posted
- 2020-07-22
- Limitations and caveats
- Small number of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Streptococcus Mutans Levels in Dental Plaque | Assessment of change in Streptococcus mutans levels 14 days after intervention | Change in Streptococcus mutans levels in dental plaque after using mouth rinses for 14 days to determine their antimicrobial efficacy. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Streptococcus Mutans Levels in Dental Plaque | Assessment of change in Streptococcus mutans levels 14 days after intervention | Group A (Children): 9 out of 10 analyzed. 1 excluded. Group A (Elderly): 9 out of 10 analyzed. 1 excluded.~Group B (Children): 9 out of 10 analyzed. 1 excluded. Group B (Elderly): 9 out of 10 were analyzed. 1 excluded.~Group C (Children): All 10 were analyzed. Group C (Elderly): 8 out of 10 were analyzed. 2 excluded. | log10CFU/g | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Streptococcus Mutans Levels in Dental Plaque | Group A (Chlorhexidine Mouthrinse) | Children (5-12 years) | 3.11 | Standard Deviation 2.32 | log10CFU/g |
| Change in Streptococcus Mutans Levels in Dental Plaque | Group B (Xylitol Mouth Rinse) | Children (5-12 years) | 0.93 | Standard Deviation 0.86 | log10CFU/g |
| Change in Streptococcus Mutans Levels in Dental Plaque | Group C (Probiotic Mouth Rinse) | Children (5-12 years) | 1.91 | Standard Deviation 1.67 | log10CFU/g |
| Change in Streptococcus Mutans Levels in Dental Plaque | Group A (Chlorhexidine Mouthrinse) | Elderly (above 60 years) | 2.23 | Standard Deviation 1.08 | log10CFU/g |
| Change in Streptococcus Mutans Levels in Dental Plaque | Group B (Xylitol Mouth Rinse) | Elderly (above 60 years) | 1.39 | Standard Deviation 0.81 | log10CFU/g |
| Change in Streptococcus Mutans Levels in Dental Plaque | Group C (Probiotic Mouth Rinse) | Elderly (above 60 years) | 1.61 | Standard Deviation 0.92 | log10CFU/g |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A (Chlorhexidine Mouthrinse) | 20 | |
| Overall Study | STARTED | Group B (Xylitol Mouth Rinse) | 20 | |
| Overall Study | STARTED | Group C (Probiotic Mouth Rinse) | 20 | |
| Overall Study | COMPLETED | Group A (Chlorhexidine Mouthrinse) | 18 | |
| Overall Study | COMPLETED | Group B (Xylitol Mouth Rinse) | 18 | |
| Overall Study | COMPLETED | Group C (Probiotic Mouth Rinse) | 18 | |
| Overall Study | NOT COMPLETED | Group A (Chlorhexidine Mouthrinse) | 2 | |
| Overall Study | NOT COMPLETED | Group B (Xylitol Mouth Rinse) | 2 | |
| Overall Study | NOT COMPLETED | Group C (Probiotic Mouth Rinse) | 2 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | irritation of oral mucosa (burning sensation in the mouth and tongue) | Gastrointestinal disorders | Group A (Chlorhexidine Mouthrinse) | 2 | 20 | |
| other | irritation of oral mucosa (burning sensation in the mouth and tongue) | Gastrointestinal disorders | Group B (Xylitol Mouth Rinse) | 0 | 20 | |
| other | irritation of oral mucosa (burning sensation in the mouth and tongue) | Gastrointestinal disorders | Group C (Probiotic Mouth Rinse) | 0 | 20 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A (Chlorhexidine Mouthrinse) | 0 | 20 |
| Total, all-cause mortality | Group B (Xylitol Mouth Rinse) | 0 | 20 |
| Total, all-cause mortality | Group C (Probiotic Mouth Rinse) | 0 | 20 |
| Total, other adverse events | Group A (Chlorhexidine Mouthrinse) | 2 | 20 |
| Total, other adverse events | Group B (Xylitol Mouth Rinse) | 0 | 20 |
| Total, other adverse events | Group C (Probiotic Mouth Rinse) | 0 | 20 |
| Total, serious adverse events | Group A (Chlorhexidine Mouthrinse) | 0 | 20 |
| Total, serious adverse events | Group B (Xylitol Mouth Rinse) | 0 | 20 |
| Total, serious adverse events | Group C (Probiotic Mouth Rinse) | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35968060 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04399161
GET https://conductscience.org/api/trials/v1/NCT04399161/registered