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Clinical efficacy evaluation of commercially available Aichijian®Medical Anti-Cavity Toothpaste

Clinical efficacy evaluation of commercially available Aichijian®Medical Anti-Cavity Toothpaste

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089643
Enrollment
Unknown
Registered
2024-09-12
Start date
2024-04-13
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

dental caries

Interventions

Test 1 - Long-term efficacy of caries prevention control group:Subjects used commercially available toothpaste A to brush their teeth, once in the morning and once in the evening, for 3 minutes each t
Test 1 - Long-term efficacy of caries prevention treatment group:Subjects used Aichijian?Medical Anti-Cavity Toothpaste to brush their teeth, once in the morning and once in the evening, for 3 minutes
Test 2 - Effects of gingivitis prevention test Group A:Subjects brushed their teeth twice a day, once in the morning and once in the evening for 3 minutes using the Pap brushing method. Brush teeth wi
Test 3 - Short-term efficacy of caries prevention control group:Subjects wore maxillary retainers embedded with 4 4mm*4mm enamel blocks throughout the day for 7 days, during which time they cleaned th
Test 3 - Short-term efficacy of caries prevention Aichijian?Medical Anti-Cavity Toothpaste group:Subjects wore maxillary retainers embedded with 4 4mm*4mm enamel blocks throughout the day for 7 days,
Test 2 - Effects of gingivitis prevention test Group B:Subjects brushed their teeth twice a day, once in the morning an

Sponsors

West China Hospital of Stomatology Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 70 Years

Inclusion criteria

Inclusion criteria: Effects of caries prevention test: (1) Children and adolescents aged 5 to 15 years old, without systemic diseases; (2) DMFT or dmft=3 or DMFS or dmfs=6; (The national standard requires the exclusion of very little or very much caries) (3) Can brush their teeth once in the morning and once in the evening, and use the toothbrush and toothpaste provided by the study as required during the study period; (4) During the study period, can accept and strictly abide by the test rules, and use the products provided by the study as required, do not use any oral care products other than the products provided, and ensure the balanced diet and daily consistent during the test period. Effects of gingivitis prevention test: (1) Aged 18 to 70 years old at the time of the test; (2) Good health, without systemic diseases; (3) At least 20 natural teeth with evaluable surfaces; (4) With dental plaque, plaque index (PI) =2.0, gingivitis, gingivitis index (GI) =1.0, bleeding index (BI) =1.0. Short-term caries prevention efficacy test: (1) Male or female students majoring in oral medicine or related practitioners aged 18 to 35 years old; (2) DMFT =2; (3) Normal salivary flow rate: stimulated salivary flow > 1 mL/min, non-stimulated salivary flow > 0.3 mL/min.

Exclusion criteria

Exclusion criteria: Effects of caries prevention test: (1) taking antibiotics in the past month;taking hormones and immunosuppressants in the past 6 months;receiving local fluoride treatment in the past 6 months; (2) daily chewing xylitol gum habit; (3) daily flossing habit; (4) wearing oral appliances, in the treatment of dental pulp disease, with visible enamel aplasia;clinical significance of oral mucosal lesions; (5) a history of high fluoride area. Effects of gingivitis test: (1) severe periodontitis, pulpitis, or oral mucosal lesions; (2) allergic to the ingredients of the test toothpaste or other oral hygiene products; (3) oral treatment or use of antibiotics in the past month; (4) daily flossing habit; (5) with poor prosthesis; (6) pregnant or lactating subjects. Short-term caries prevention efficacy test: (1) active caries lesions in the mouth; (2) allergic to the ingredients of the test toothpaste or other oral hygiene products; (3) abnormal dental development diseases: enamel aplasia, dental fluorosis, tetracycline teeth, etc.; (4) gingivitis, periodontitis (at least one tooth of the periodontal pocket depth = 5.5 mm) (5) undergoing orthodontic treatment; (6) taking antibiotics or antibacterial mouthwash in the month before the experiment, which may interfere with the activity of the flora; (7) pregnancy or lactation; (8) smoking.

Design outcomes

Primary

MeasureTime frame
Biomembrane metagenomic sequencing(Test 3);Surface microhardness difference(Test 3);Transverse microradiography(Test 3);dmft&dmfs(test 1);DMFT&DMFS(test 1);16S rDNA high-throughput sequencing(Test 2);

Secondary

MeasureTime frame
Determination of extracellular polysaccharide in biofilms(Test 3);CFU count of biofilm viable bacteria(Test 3);scanning electron microscope(Test 3);Energy Dispersive Spectrometer(Test 3);Polarizing microscope(Test 3);Plaque index(Test 2);Gingival indices(GI)(Test 2);Sulcus Bleeding Index(SBI)(Test 2);bleeding on probing(BOP)(Test 2);

Countries

China

Contacts

Public ContactZhang Linglin

West China Hospital of Stomatology Sichuan University

zhll_sc@163.com+86 139 0807 3896

Outcome results

None listed

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