Clinical trial NCT06048627: Anti-gingivitis Mouthrinse
Official title: Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 daily during brushing at home over a period of 12 weeks.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Whole-mouth Mean Modified Gingival Index (MGI)
timeFrame: Baseline, 3 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Turesky Modification of the Quigley Hein Plaque Index (PI)
timeFrame: Baseline, 3 weeks, 12 weeks, 24 weeks
measure: Intraoral scans
timeFrame: Baseline, 3 weeks, 12 weeks, 24 weeks
measure: Patient-reported experiences
timeFrame: Baseline, 3 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden
Study officials:
References: