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Efficacy and safety of biopeptide-containing repair toothpaste in alleviating minor recurrent aphthous ulcer: a randomized, double-blind and placebo-controlled clinical trial

Efficacy and safety of biopeptide-containing repair toothpaste in alleviating minor recurrent aphthous ulcer: a randomized, double-blind and placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062299
Enrollment
Unknown
Registered
2022-08-01
Start date
2022-08-10
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Minor Recurrent Aphthous Ulcer

Interventions

The experimental group:Biopeptide-containing repair toothpaste
The control group:Placebo toothpaste wtihous biopeptide

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged range from 18 to 65 years; 2. History of recurrent Aphthous ulcer >=6 months, total occurrence times >=3; 3. Diagnosed as mild recurrent Aphthous ulcer, the number of ulcers was 1-3, and the diameter of ulcers was 2-9 mm; 4. The onset time of the ulcer was less than 48 hours without medication intervention; 5. The ulcer site is convenient for clinical examination; 6. Sign informed consent and be able to complete clinical trials as required.

Exclusion criteria

Exclusion criteria: 1. Recurrent herpetic Aphthous ulcer, Behcet's disease or other serious oral mucosal diseases (such as oral lichen planus, bullotic disease, oral candidiasis, etc.); 2. Suffering from serious systemic, infectious or autoimmune diseases; 3. Used glucocorticoids, immunosuppressive drugs, antibiotics, etc., within 1 month; used ulcer related local drugs within 1 week, etc.; 4. Allergic constitution or allergic history of the test product ingredients; 5. Laboratory inspection indicators are abnormal, exceeding 1.5 times of the upper/lower limit of normal value; 6. Patients of childbearing age during pregnancy, lactation or planning to become pregnant; 7. Smokers/alcoholics; 8. Participated in other clinical trials within 3 months; 9. Other circumstances not considered suitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Target ulcer healing time;Ulcer pain index (Numerical rating scale (NRS) pain score);Healing rate of target ulcer;

Secondary

MeasureTime frame
Target ulcer area;Satisfaction of subjects using the experimental product;

Countries

China

Contacts

Public ContactZhou Hongmei

West China Hospital of Stomatology, Sichuan University

acomnet@126.com+86 28 85503480

Outcome results

None listed

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