Clinical Study Examining the Control of Plaque and Gingivitis

NCT07842978 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CRO-2026-06-GIN-NOS-YPZ
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.

Conditions

Gingivitis

Keywords

plaque

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. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored. 0 = Absence of inflammation 1. = Mild inflammation - slight change in color and little change in texture 2. = Moderate inflammation - moderate glazing, redness, edema and hypertrophy 3. = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.

  Baseline, 3 month, 6 month

• Quigley-Hein Plaque Index

  First using a red solution to dye the plaque, 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. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.

  Baseline, 3 month, 6 month

Study Arms (3)

Test 1 toothpaste

EXPERIMENTAL

Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.

Drug: Silica Free Meridol

Test 2 toothpaste

ACTIVE COMPARATOR

Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.

Drug: Meridol

Test 3 toothpaste

ACTIVE COMPARATOR

Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily.

Drug: Colgate Dental Product

Interventions

Silica Free Meridol DRUG

Toothpaste

Test 1 toothpaste

Meridol DRUG

Toothpaste

Test 2 toothpaste

Colgate Dental Product DRUG

MFP fluoride toothpaste

Test 3 toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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 which prohibits eating or drinking for periods up to 4 hours.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Interventions

Meridol

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Deyu Hu, DDS, MS

  West China Dental Institute of Chengdu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deyu Hu, DDS, MS

CONTACT

86-1390-803-4990; hudeyu@vip.sina.com

Yisi Zhong, DDS, PhD

CONTACT

86-1388-228-6537; zhongyisi@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 21, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)