Clinical trial of a toothpaste containing enzyme (dextranase) on the control of dental plaque
| ISRCTN | ISRCTN24643598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24643598 |
- Submission date
- 01/08/2025
- Registration date
- 11/08/2025
- Last edited
- 11/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
To evaluate the efficacy of a toothpaste containing dextranase, an enzyme that degrades α-1,6 glycosidic bonds in glucans, both alone and in combination with isopropyl methylphenol (IPMP), a non-ionic antimicrobial agent, for inhibiting dental plaque.
Who can participate?
Adults aged 19–70 years in generally good health, with no major systemic illness or oral injuries, who have at least 20 natural teeth (including 4 molars, excluding third molars), are not currently in other trials, and have a plaque index (PI) score of 2 or higher. Participants must also be able to complete the trial and give informed consent.
What does the study involve?
Participants were randomly assigned to one of three toothpaste groups and instructed to brush their teeth twice daily for 8 weeks using only the assigned products. Their dental plaque was assessed at baseline and after 2, 4, and 8 weeks using a standardized index. No other oral hygiene products were allowed. Oral examinations, plaque staining, and PI scoring were conducted by trained professionals.
What are the possible benefits and risks of participating?
Oral plaque inhibition
Where is the study run from?
The study was conducted at the Chongqing Medical University (China)
When is the study starting and how long is it expected to run for?
April 2024 to October 2024
Who is funding the study?
Lion Corporation, Japan
Who is the main contact?
Dr Zhou Zhi, zhouzhi_050918@hotmail.com
Contact information
Public, Scientific, Principal Investigator
No. 426, Songshi North Road, Yubei District
Chongqing
401147
China
 ORCID ID |
0000-0001-7402-0037 |
|---|---|
| Phone | +86-23-88860111 |
| zhouzhi_050918@hotmail.com |
Study information
| Study design | Randomized double-blind parallel-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Efficacy |
| Scientific title | Clinical trial of a toothpaste containing enzyme (dextranase) on the control of dental plaque |
| Study objectives | Both test toothpastes—with dextranase alone or in combination with IPMP—significantly reduce the plaque index compared with the control. Additionally, superior plaque inhibition is observed for the formulation combining a higher dose of dextranase with IPMP. |
| Ethics approval(s) |
Approved 30/05/2024, The Ethics Committee of the Stomatological Hospital of Chongqing Medical University (No. 426, Songshi North Road, Yubei District, Chongqing, 401147, China; +86-23-88602305; kqyyirb@163.com), ref: No. 2024 Ethics Review 084 |
| Health condition(s) or problem(s) studied | Plaque control in healthy individuals |
| Intervention | 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 used for each brushing was enough to cover the entire length of the brush head. Group 1: Toothpaste containing dextranase alone, brushing twice daily (morning and night) for 2 minutes each time. Group 2: Toothpaste containing dextranase + isopropyl methylphenol (IPMP), brushing twice daily (morning and night) for 2 minutes each time. Group 3: Control toothpaste without dextranase or IPMP, brushing twice daily (morning and night) for 2 minutes each time. All participants were instructed to refrain from using any other oral care products (toothpaste, toothbrushes, mouthwashes, dental floss, toothpicks) during the study. Follow-up assessments: Baseline, 2 weeks, 4 weeks, and 8 weeks. Randomisation: Randomisation was performed using a computer-generated randomisation list, stratified by baseline plaque index (PI), age, and gender to ensure balanced allocation between groups. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | There are no secondary outcome measures |
| Overall study start date | 02/04/2024 |
| Completion date | 02/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 180 |
| Total final enrolment | 186 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/06/2024 |
| Date of final enrolment | 20/06/2024 |
Locations
Countries of recruitment
- China
Study participating centre
401147
China
Sponsor information
Industry
7-2-1, Hirai, Edogawa-ku
Tokyo
1320035
Japan
| Phone | +81 8022126413 |
|---|---|
| chika_a@lion.co.jp | |
| Website | http://www.lion.co.jp/en/ |
"ROR" |
https://ror.org/01bt8n520 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lion, Lion Corp, Lion Corporation Japan, ライオン株式会社
- Location
- Japan
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Zhi Zhou (zhouzhi_050918@hotmail.com) |
Editorial Notes
01/08/2025: Trial's existence confirmed by The Ethics Committee of the Stomatological Hospital of Chongqing Medical University.
