## Protocol Section
### Identification Module
**NCT ID:** NCT06437262

**Brief Title:** Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva

**Official Title:** Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva

#### Organization Study ID Info
**ID:** 2021-CE161
#### Organization
**Class:** OTHER
**Full Name:** University of Santiago de Compostela
### Status Module
#### Completion Date
**Date:** 2023-07-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Lacer, S.A.

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Santiago de Compostela

#### Responsible Party

**Investigator Affiliation:** University of Santiago de Compostela

**Investigator Full Name:** Inmaculada Tomás

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application.

### Conditions Module

**Conditions:**

- Healthy

- Saliva

- Biofilms

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.

**Intervention Names:**

- Drug: 0.20% CHX gel on saliva

- Drug: 0.20% CHX gel on oral biofilm

**Label:** 0.20% CHX gel

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application.

**Intervention Names:**

- Drug: 0.20% CHX and Cymenol gel on saliva

- Drug: 0.20% CHX and Cymenol gel on oral biofilm

**Label:** 0.20% CHX and Cymenol gel

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 0.20% CHX gel

**Description:** In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.

**Name:** 0.20% CHX gel on saliva

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 0.20% CHX and Cymenol gel

**Description:** In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points.

**Name:** 0.20% CHX and Cymenol gel on saliva

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 0.20% CHX gel

**Description:** Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.

**Name:** 0.20% CHX gel on oral biofilm

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- 0.20% CHX and Cymenol gel

**Description:** Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points.

**Name:** 0.20% CHX and Cymenol gel on oral biofilm

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes

**Measure:** Intragel bacterial viability: baseline vs 5 minutes

**Time Frame:** Baseline vs 5 minutes

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour

**Measure:** Intragel bacterial viability: baseline vs 1 hour

**Time Frame:** Baseline vs 1 hour

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours

**Measure:** Intragel bacterial viability: baseline vs 3 hours

**Time Frame:** Baseline vs 3 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours

**Measure:** Intragel bacterial viability: baseline vs 5 hours

**Time Frame:** Baseline vs 5 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours

**Measure:** Intragel bacterial viability: baseline vs 7 hours

**Time Frame:** Baseline vs 7 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour

**Measure:** Intragel bacterial viability: 5 minutes vs 1 hour

**Time Frame:** 5 minutes vs 1 hour

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours

**Measure:** Intragel bacterial viability: 5 minutes vs 3 hours

**Time Frame:** 5 minutes vs 3 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours

**Measure:** Intragel bacterial viability: 5 minutes vs 5 hours

**Time Frame:** 5 minutes vs 5 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours

**Measure:** Intragel bacterial viability: 5 minutes vs 7 hours

**Time Frame:** 5 minutes vs 7 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

**Measure:** Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel

**Time Frame:** Baseline

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

**Measure:** Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel

**Time Frame:** 5 minutes

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

**Measure:** Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel

**Time Frame:** 1 hour

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

**Measure:** Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel

**Time Frame:** 3 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

**Measure:** Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel

**Time Frame:** 5 hours

**Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel.

**Measure:** Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel

**Time Frame:** 7 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Systemically healthy volunteers
* Age between 20-45 years
* Presence of minimum 24 permanent teeth
* No evidence of gingivitis or periodontitis (CPITN= 0)
* No presence of untreated caries at the start of the study

Exclusion Criteria:

* Smoker or ex-smoker
* Presence of dental protheses or orthodontic appliances
* Antibiotic treatment and/or routine use of oral antiseptics in the previous three months
* Presence of any systemic disease that could alter saliva production or composition

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Santiago de Compostela

**Country:** Spain

**Facility:** University of Santiago de Compostela

**State:** A Coruña

**Zip:** 15782

#### Overall Officials

**Official 1:**

**Affiliation:** University of Santiago de Compostela, Spain

**Name:** Inmaculada Tomás, Prof

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5953

- Name: Chlorhexidine

- Relevance: LOW

- As Found: Unknown

- ID: M344731

- Name: Chlorhexidine gluconate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
