Status:
COMPLETED
Anti-gingivitis Mouthrinse
Lead Sponsor:
Colgate Palmolive
Conditions:
Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice...
Eligibility Criteria
Inclusion
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
- Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
- Signed Informed Consent Form.
Exclusion
- Presence of orthodontic bands.
- Malign tumor(s) of the soft or hard tissues of the oral cavity.
- Antibiotic use any time during the one-month period prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome.
- An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
- History of alcohol or drug abuse.
- Self-reported pregnant or lactating subjects.
- Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
- Participants who require antibiotic treatments for dental appointments.
- Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index \[PSI\] \>2 in more than 2 sextants or PSI \>3).
- Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
- Smokers or/and users of tobacco products.
- Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06048627
Start Date
March 6 2024
End Date
October 1 2024
Last Update
May 21 2025
Active Locations (1)
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1
Technische Universität Dresden
Dresden, Germany, 01307