Anti-gingivitis Mouthrinse

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Gingivitis

Treatments

Drug: Amine/zinc lactate/fluoride system

Drug: negative control

Study type

Interventional

Funder types

Industry

Identifiers

NCT06048627

CRO-2022-10-MER-MW-JG

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)