NCT06563518

Brief Summary

The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 19, 2024

Last Update Submit

August 19, 2024

Conditions

GingivitisPlaque

Outcome Measures

Primary Outcomes (2)

  • Gingivitis Assessment

    A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.

    baseline, 3 months and 6 months

  • Plaque Assessment

    A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror

    baseline, 3 months and 6 months

Study Arms (2)

Group 1

EXPERIMENTAL

Toothpaste

Drug: Meridol

Group II

ACTIVE COMPARATOR

Toothpaste

Drug: Colgate Cavity Protection

Interventions

MeridolDRUG

toothpaste

Group 1
Colgate Cavity ProtectionDRUG

toothpaste

Group II

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects, ages 18-70, inclusive.
  • 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 1.0 as determined by the use of the Loe and Silness Gingival Index.
  • Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
  • Signed Informed Consent Form

You may not qualify if:

  • Presence of orthodontic bands.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
  • Five or more carious lesions requiring immediate restorative treatment.
  • 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.
  • Pregnant or lactating subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Seriwatanachai D, Triratana T, Kraivaphan P, Huber N, Poth T, Mateo LR, Stellitano M, Zhang YP. Effectiveness of a novel amine + zinc + fluoride toothpaste in reducing plaque and gingivitis: results of a six-month randomized controlled trial. BMC Oral Health. 2025 Feb 5;25(1):188. doi: 10.1186/s12903-025-05551-z.

    PMID: 39910536DERIVED

MeSH Terms

Conditions

GingivitisPlaque, Amyloid

Interventions

Meridol

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Terdphong Triratana

    Managing Director of Dental Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

January 18, 2022

Primary Completion

July 10, 2022

Study Completion

July 10, 2022

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)