Gingivitis
Conditions
Interventions
Experimental group:Enzymatic toothpaste
Control group:Placebo toothpaste (enzyme free)
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Generally healthy males and females 18-65 years of age. 2. Able to read, sign and receive a copy of the signed informed consent form. 3. Have at least 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not be include in the tooth count. 4. Willing to refrain from all oral hygiene 8-12 hours prior to each study visit and discontinue eating and drinking at least 4 hours prior to each study visit. 5. At the Baseline Visit, prior to the dental prophylaxis, subject presents with: a. A gingival index score of = 1.75 and = 2.3 according to the Modified Gingival Index. b. A plaque index score = 1.95 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following 8 to 16 hours plaque accumulation period. 6. Willing and able to comply with scheduled visits, treatment plan and other study procedures. 7. Willing to refrain from the use of chemotherapeutic antiplaque/antigingivitis products containing antibacterial agents such as, but not limited to, amine fluoride, chlorhexidine, stannous fluoride, essential oils, cetylpyridinium chloride, etc. and other oral hygiene products during the study. 8. No self-reported serious medical conditions. 9. Subject is not currently pregnant, or breastfeeding and subject does not intend to become pregnant through the duration of the study. Pregnancy and breastfeeding are not exclusion factors for safety reasons, but due to the exaggerated gingival inflammatory response associated with hormonal changes. 10. No requirement for antibiotic premedication prior to dental procedures. 11. No current history of antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of Screening visit. 12. Subject is not a smoker or user of smokeless tobacco, due to the impact of smoking and tobacco products on inflammation and bleeding. 13. No moderate or severe periodontal disease or actively under treatment for periodontal disease. 14. No orthodontic appliances, peri/oral piercings, or removable partial dentures. 15. No history of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients. 16. If female, not pregnant or nursing. 17. Not smoking or using of other nicotine products.
Exclusion criteria
Exclusion criteria: 1. Employees of the testing center or the sponsoring unit who directly participate in the conduct of the study or are immediate family members of the researchers; or employees of testing centers supervised by the researchers; 2. Subjects whose health conditions, as determined by the researchers, may prevent them from fully complying with or completing the study; or whose participation in the study may increase their own health risks; 3. Subjects with a history of allergies or significant adverse events after using oral hygiene products (such as toothpaste, mouthwash, breath mints, lozenges, chewing gum, or their ingredients); 4. Subjects who have participated in other studies involving the test product (including non-drug studies) within 30 days prior to enrollment in this study or during the study period; 5. Female subjects who are lactating, pregnant, or planning to become pregnant during the study; 6. Subjects who self-report having a serious illness; 7. Subjects with uncontrolled hypertension or diabetes; 8. Subjects with a history of antibiotic, anti-inflammatory, or chemical therapy for plaque/gingivitis treatment within 30 days prior to the screening visit; 9. Subjects who smoke or use other nicotine products; 10. Subjects who are required to take prophylactic antibiotics before dental treatment procedures to prevent infective endocarditis; 11. Subjects who regularly use steroidal or non-steroidal anti-inflammatory drugs; 12. Subjects unwilling to discontinue the use of other oral hygiene products (such as anti-plaque/anti-gingivitis mouthwash or toothpaste, electric toothbrushes, oral irrigators/water flossers) during the study; 13. Subjects with clinically visible active caries lesions and/or periodontitis; 14. Subjects with visually significant oral soft tissue lesions due to pathology or trauma; 15. Subjects wearing any form of orthodontic appliances (including braces), having oral piercings, or wearing removable dentures; 16. Subjects with periodontal disease stages II - IV or ongoing periodontal treatment, or with =30% of teeth in periodontal disease stages II - IV, according to the Classification System of Periodontal and Peri-Implant Diseases and Conditions revised by the American Academy of Periodontology at the screening and/or baseline visit; 17. Subjects with periodontal pocket depths greater than 5mm in more than 3 teeth; 18. Subjects whom the researchers consider ineligible for participation in the study for any reason; 19. Subjects with abnormal preoperative tests (blood routine, coagulation function, HIV, hepatitis, syphilis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the mean plaque index (PLI) score on day 28; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the mean gingival severity score on day 14 and day 28;Changes in the mean plaque index (PLI) score on day 1 and day 14;Changes in the mean plaque severity score on day 1, day 14, and day 28;Changes in the mean gingivitis index (GI) on day 14 and day 28;Examination of Oral Soft and Hard Tissue(Safety indicator); | — |
Countries
China
Contacts
Public ContactYu Zhou
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed