## Protocol Section
### Identification Module
**NCT ID:** NCT06430060

**Brief Title:** The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis

**Official Title:** The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis (A Threemonth Clinical Study)

#### Organization Study ID Info
**ID:** CRO-2024-03-GIN-DZN-CN-YPZ
#### Organization
**Class:** INDUSTRY
**Full Name:** Colgate Palmolive
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Colgate Palmolive

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.

### Conditions Module

**Conditions:**

- Plaque, Dental

- Gingivitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** toothpaste

**Intervention Names:**

- Drug: zinc containing toothpaste

**Label:** Colgate Dual Zinc Toothpaste

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** toothpaste

**Intervention Names:**

- Drug: MFP Fluoride toothpaste

**Label:** Colgate Cavity Protection Toothpaste

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Colgate Dual Zinc Toothpaste

**Description:** Toothpaste

**Name:** zinc containing toothpaste

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Colgate Cavity Protection Toothpaste

**Description:** toothpaste

**Name:** MFP Fluoride toothpaste

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Loe-Silness Gingival Index score

**Time Frame:** baseline, 2 week, 6 week, 3 month

**Description:** 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.

**Measure:** Quigley-Hein Plaque Index score

**Time Frame:** baseline, 2 week, 6 week, 3 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the three-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

Exclusion Criteria:

* 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.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hudeyu@vip.sina.com

**Name:** Deyu Hu, DDS, MS

**Phone:** 86-1390-803-4990

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chengdu

**Country:** China

**Facility:** West China Dental Institute of Chengdu

**State:** Sichuan

**Zip:** 610041

#### Overall Officials

**Official 1:**

**Affiliation:** West China Dental Institute of Chengdu

**Name:** Deyu Hu, DDS, MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000005882

- Term: Gingival Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000003741

- Term: Dental Deposits

- ID: D000014076

- Term: Tooth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9003

- Name: Gingivitis

- Relevance: HIGH

- As Found: Gingivitis

- ID: M6970

- Name: Dental Plaque

- Relevance: HIGH

- As Found: Plaque, Dental

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8994

- Name: Gingival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6938

- Name: Dental Deposits

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005891

- Term: Gingivitis

- ID: D000003773

- Term: Dental Plaque

### Intervention Browse Module - Ancestors

- ID: D000002327

- Term: Cariostatic Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M8587

- Name: Fluorides

- Relevance: HIGH

- As Found: Genetic

- ID: M140080

- Name: Listerine

- Relevance: LOW

- As Found: Unknown

- ID: M15771

- Name: Sodium Fluoride

- Relevance: LOW

- As Found: Unknown

- ID: M17768

- Name: Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005459

- Term: Fluorides

### Misc Info Module

- Version Holder: 2024-05-31
