## Protocol Section
### Identification Module
**NCT ID:** NCT02829879

**Brief Title:** Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

**Official Title:** Comparison of the Clinical Effectiveness of 8% Arginine/1450 Ppm Sodium Monofluorophosphate Versus 5% Potassium Nitrate/2500 Ppm Sodium Fluoride in Dentin Hypersensitivity Therapy: A Randomized Controlled Clinical Trial

#### Organization Study ID Info
**ID:** FIOUCh 13-103
#### Organization
**Class:** OTHER
**Full Name:** University of Chile
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2016-07-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-07-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-12

**Status Verified Date:** 2016-07

#### Study First Post Date
**Date:** 2016-07-12
**Type:** ESTIMATED
**Study First Submit Date:** 2016-07-08
**Study First Submit QC Date:** 2016-07-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Chile

#### Responsible Party

**Investigator Affiliation:** University of Chile

**Investigator Full Name:** Patricia Hernández-Ríos

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. Multiple therapies for the treatment of DH have been studied, including equivocal evidence about the efficacy of potassium nitrate salts and recent investigations a promising new 8% Arginin dentifrice.

Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2) dentifrices in the treatment of dentin hypersensitivity.

Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile, with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450 ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH) measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and 8 week follow-up. The data will be analysed through Stata® V11 program.

### Conditions Module

**Conditions:**

- Dentin Sensitivity

**Keywords:**

- Dentin Sensitivity

- Arginin

- Potassium Nitrate

- Dentifrice

- RCT

### 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:** 50

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 25 volunteers with dentin sensitivity

**Intervention Names:**

- Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice

**Label:** arginine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 25 volunteers with dentin sensitivity

**Intervention Names:**

- Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice

**Label:** potassium nitrate

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- arginine

**Name:** 8% arginine/1450ppm sodium monofluorophosphate dentifrice

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- potassium nitrate

**Name:** 5% potassium nitrate/2500ppm sodium fluoride dentifrice

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Differences in mean VAS score per subject

**Time Frame:** Baseline, 4 and 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age between 18 and 70 years
* Dentin sensitivity in at least 2 teeth (incisors, cuspids and/or bicuspids) with a VAS score ≥4
* Good general health

Exclusion Criteria:

* Defective or extensive restorations, deep dental caries, pulpitis, chipped teeth,
* Bridgework, dentures or crowned teeth that could interfere with the evaluation of hypersensitivity
* Pregnancy or lactation
* Ongoing treatment with anti-inflammatory or sedative drugs
* Systemic conditions that are etiologic or predisposing to dentine hypersensitivity, like chronic acid regurgitation
* Ongoing periodontal therapy or periodontal surgery in the preceding 3 months
* Allergic responses to the dentifrices
* Hypersensitivity treatment in the preceding 3 months

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** phernandezrios@gmail.com

**Name:** Patricia Hernández-Ríos, Professor

**Phone:** +56229781839

**Role:** CONTACT

**Contact 2:**

**Email:** dra.j.contreras@gmail.com

**Name:** Johanna Contreras, Professor

**Phone:** +56229781839

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Santiago

**Contacts:**

***Contact 1:***

- **Email:** phernandezrios@gmail.com

- **Name:** Patricia Hernández-Ríos, Professor

- **Phone:** +56229781839

- **Role:** CONTACT

**Country:** Chile

**Facility:** Faculty of Dentistry, University of Chile

**State:** Región Metropolitana

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: HIGH

- As Found: Hypersensitivity

- ID: M7003

- Name: Dentin Sensitivity

- Relevance: HIGH

- As Found: Dentin Sensitivity

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003807

- Term: Dentin Sensitivity

- ID: D000006967

- Term: Hypersensitivity

### Intervention Browse Module - Ancestors

- ID: D000002327

- Term: Cariostatic Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000891

- Term: Anti-Infective Agents, Local

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M8587

- Name: Fluorides

- Relevance: HIGH

- As Found: Concentration

- ID: M140080

- Name: Listerine

- Relevance: HIGH

- As Found: 1.2

- ID: M15771

- Name: Sodium Fluoride

- Relevance: HIGH

- As Found: 1.2

- ID: M247884

- Name: Fluorophosphate

- Relevance: HIGH

- As Found: 5-Azacytidine

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4215

- Name: Anti-Infective Agents, Local

- Relevance: LOW

- As Found: Unknown

- ID: T1

- Name: Arginine

- Relevance: HIGH

- As Found: Radical

### Intervention Browse Module - Meshes

- ID: C000057473

- Term: Listerine

- ID: D000005459

- Term: Fluorides

- ID: D000012969

- Term: Sodium Fluoride

- ID: C000012980

- Term: Fluorophosphate

### Misc Info Module

- Version Holder: 2024-05-24
