Anti-gingivitis Mouthrinse

Sponsor

Colgate Palmolive (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06048627

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Drug: Amine/zinc lactate/fluoride system Drug: negative control	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mouthwash Test	Drug: Amine/zinc lactate/fluoride system Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive
Experimental: Mouthwash Experimental	Drug: negative control Sodium fluoride mouthwash 250 ppm

Arm

Intervention/Treatment

Active Comparator: Mouthwash Test

Drug: Amine/zinc lactate/fluoride system

Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive

Experimental: Mouthwash Experimental

Drug: negative control

Sodium fluoride mouthwash 250 ppm

Outcome Measures

Primary Outcome Measures

difference of reduction in gingival index (Löe 1967) [baseline]
from baseline to 6 months between test and control groups
difference of reduction in gingival index (Löe 1967) [6 months between test and control groups]
from baseline to 6 months between test and control groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Technische Universität Dresden	Dresden		Germany	01307

Sponsors and Collaborators

Colgate Palmolive

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT06048627

Other Study ID Numbers:

CRO-2022-10-MER-MW-JG

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Fluorides

Study Results

No Results Posted as of Sep 21, 2023