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Clinical Efficacy Study on the Effects of Toothpaste in Combating Bad Breath

Clinical Efficacy Study on the Effects of Toothpaste in Combating Bad Breath

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102552
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-04
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bad Breath

Interventions

Test Product Group:Study participants use the test product toothpaste containing probiotics for brushing teeth, twice daily, once in the morning and once in the evening.
Placebo Group:Study participants use placebo toothpaste without probiotics for brushing teeth, twice daily, once in the morning and once in the evening.

Sponsors

Stomatological Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chinese men or women with good health conditions, aged between 18-65 years old (inclusive) during screening; 2. Able to read, sign, and receive signed copies of informed consent forms; 3. Willing and able to comply with the scheduled visit time, treatment plan, and other research procedures; 4. Overall good oral health, with at least 20 natural teeth; When screening, the condition of teeth and gums should be checked first. Only those who pass the examination can participate in this study; When screening and baseline breath detection, the measured VSC value of the Halimeter is>=200ppb; 6. The baseline score for breath and smell is greater than 1 point; 7. Willing not to clean the mouth in any form 8-16 hours before each research visit, not to consume any food or drink other than water in the morning of each visit, and to stop drinking water 30 minutes before the start of the visit. 8. No AIDS or other serious diseases 9. No wearing of any form of orthodontic appliance, no oral perforation, and no removable dentures. 10. There is no history of allergies or significant adverse events after using oral hygiene products such as toothpaste, mouthwash, mint candies, lozenges, chewing gum, or their ingredients.

Exclusion criteria

Exclusion criteria: 1. Participate in other studies (including non pharmaceutical studies) involving the investigational product within 30 days prior to enrollment and/or during the study period; 2. Female research participants who are breastfeeding, pregnant, or planning to become pregnant during the study period will be verbally confirmed during screening; 3. Unintentionally or unable to comply with the product usage instructions or lifestyle described in this research protocol; 4. Regularly drinking alcohol, smoking, or using tobacco products; 5. Research participants who are known or suspected to be intolerant or allergic to the research material (or closely related compounds) or any of its established ingredients; 6. Have a history of allergies to personal consumer products and their ingredients; 7. Accompanied by dry mouth, acute oral inflammation (such as acute pulpitis, maxillofacial space infection, periodontitis, oral ulcers, etc.), oral tumors, periodontitis; 8. Have sinus disease, gastric reflux, diabetes, liver or kidney disease and other systemic or systemic diseases; 9. Patients with partial or complete dentures, or with poor restorations; 10. Have undergone oral treatment or used antibiotics within the past month; On the day of screening, use products containing phenolic or peppermint flavors, such as mouthwash, chewing gum, etc; 12. During baseline visits, identify women who will enter their menstrual period within the next two weeks; 13. Those who cannot comply with the experimental requirements due to physical reasons; 14. Those who cannot meet the fasting or drinking requirements within the evaluation period due to medical reasons; 15. Researchers believe that any research participant should not participate in the study.

Design outcomes

Primary

MeasureTime frame
Breath Odor Sensory Score;

Secondary

MeasureTime frame
Winkel tongue coating index;Halimeter Instrument Measurement Value;Saliva pH Value;Saliva Microbial Detection;

Countries

China

Contacts

Public ContactMeng Wenxia

Stomatological Hospital of Southern Medical University

37709882@qq.com+86 159 1581 8004

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026