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Clinical trial of a toothpaste containing enzyme (dextranase) on the control of dental plaque

Clinical trial of a toothpaste containing enzyme (dextranase) on the control of dental plaque

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24643598
Enrollment
180
Registered
2025-08-11
Start date
2024-06-02
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Plaque control in healthy individuals Oral Health

Interventions

The participants were instructed to brush their teeth twice a day, once in the morning and once at night, for 2 min each time using the provided toothpaste and toothbrush. The amount of toothpaste use

Sponsors

Lion Corporation (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. They were in good overall health, had no significant systemic diseases, had no injuries inside or outside the oral cavity, and had at least 20 testable teeth. Excluding the third molars, they must have at least four molars 2. They were between the ages of 19 and 70 years 3. They were not participating in other similar trials simultaneously 4. They could complete the clinical trial as required if they signed the informed consent 5. Based on the claimed efficacy of the product and clinical trial design, participants must have an appropriate level of plaque, with a baseline PI score of =2

Exclusion criteria

Exclusion criteria: 1. They had orthodontic appliances, implants, locally movable dentures, or orthodontic retainers in their oral cavity 2. They had severe diseases such as oral soft and hard tissue tumors 3. They had two or more teeth that needed immediate treatment or had mucosal lesions 4. They were participating in other clinical trials 5. They had a history of hypersensitivity to the test toothpaste ingredients 6. They had used antibiotics within the last month 7. They planned to receive treatment at a dental clinic during the test period 8. They were pregnant or breastfeeding or planned to become pregnant during the test period 9. They were smokers, including electronic cigarettes, or had a recent history of smoking

Design outcomes

Primary

MeasureTime frame
Plaque index measured using the Turesky modification of the Quigley–Hein index at baseline, 2 weeks, 4 weeks, and 8 weeks, assessed by trained dental examiners using plaque disclosing agents.

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

China

Contacts

Public ContactZhi Zhou
zhouzhi_050918@hotmail.com+86-23-88860111

Outcome results

None listed

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