## Protocol Section
### Identification Module
**NCT ID:** NCT01336179

**Brief Title:** Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health

**Official Title:** The Efficacy of the Miswak Chewing Sticks (Salvadora Persica)on Plaque Removal and Gingival Health: Randomised Clinical Trial

#### Organization Study ID Info
**ID:** UTFD201127021
#### Organization
**Class:** OTHER
**Full Name:** Taibah University
### Status Module
#### Completion Date
**Date:** 2011-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-06-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-05-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Start Date
**Date:** 2011-03

**Status Verified Date:** 2011-04

#### Study First Post Date
**Date:** 2011-04-15
**Type:** ESTIMATED
**Study First Submit Date:** 2011-04-06
**Study First Submit QC Date:** 2011-04-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taibah University

#### Responsible Party

**Old Name Title:** Dr Tareq Abu Saleh

**Old Organization:** Department of Preventive Dental Sciences, Faculty of Dentistry, Taibah University

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the toothbrushes on plaque removal and gingival health.

**Detailed Description:** Dental plaque removal is essential in maintaining oral health. Methods for oral hygiene vary from country to country and from culture to culture. The use of a wood stick (miswak or chewing stick) for brushing the teeth is considered an important tool for oral hygiene care in many Afro-Asian communities. The aim of the study is to compare the effect of the chewing stick (miswak), and toothbrushing on plaque removal and gingival health. The participants comprise 18 healthy Saudi Arabian male volunteers aged 21 to 30 years, at Taibah University in Saudi Arabia. The study was designed as a single, blind, randomized split-mouth study. Professional tooth cleaning was conducted, and after six weeks use of either the miswak or toothbrush on each quadrant, modified plaque and gingival indices, were recorded.

### Conditions Module

**Conditions:**

- Plaque Induced Gingivitis

**Keywords:**

- gingivitis

- dental plaque

- oral hygiene

- toothbrush

- chewing sticks

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 18

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Salvadora persica

**Label:** Miswak, dental plaque and gingivitis

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: Toothbrush

**Label:** Toothbrush, dental plaque and gingivitis

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Miswak, dental plaque and gingivitis

**Description:** twice daily use, two minutes interval

**Name:** Salvadora persica

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Toothbrush, dental plaque and gingivitis

**Description:** Twice daily use two minutes interval

**Name:** Toothbrush

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Miswak will be compared to toothbrush as a mechanical plaque control device, by calculating plaque index and gingival index scores for participants after 6 weeks of use.

**Measure:** Miswak is useful for removing plaque and preventing gingivitis

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy individuals
* presence of at least 14 teeth

Exclusion Criteria:

* Subjects on medications (antiinflammatory or antibiotics)

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Almadinah

**Country:** Saudi Arabia

**Facility:** Faculty of Dentistry Taibah University

**Zip:** 04

#### Overall Officials

**Official 1:**

**Affiliation:** Assistant professor in Periodontics, Taibah University

**Name:** Tareq AS Abu Saleh, MSc, MRD

**Role:** PRINCIPAL_INVESTIGATOR

## 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

### 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: LOW

- As Found: Unknown

- 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

### Condition Browse Module - Meshes

- ID: D000005891

- Term: Gingivitis

### Misc Info Module

- Version Holder: 2024-05-24
