Effect of Miswak and Miswak Extract on Oral Malodor

NCT02628938 | Completed Phase 2 Results

• 1 other identifier: FUGRP/2013/114
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this experiment is to investigate the effect of Miswak on oral malodor and to determine whether this effect -if present- is the result of the mechanical action of Miswak or the chemical effect of its extract

Conditions

Oral Malodor; Halitosis

Keywords

Halitosis; Oral Malodor; Miswak; Salvadora Persica

Outcome Measures

Primary Outcomes (1)

• Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).

  The Organoleptic scores were obtained by a calibrated judge who first tested her ability to detect and distinguish odors even at low concentrations using the Smell Identification Test (Sensonics Inc., Haddon Heights, NJ, USA). To obtain the score, the patient was asked to close her mouth for approximately 3 minutes while breathing only from the nose. Then he/she was asked to release air from the mouth slowly. The judge kept a distance of about 10 cm between her nose and the patient's mouth to determine the score based on the intensity of the odor. The intensity ratings of 0 to 5 score was used where Score 0 stands for "No odor present", score 1 stands "barely noticeable odor", score 2 stands "slight but clearly noticeable odor", score 3 stands "moderate odor", score 4 stands "strong offensive odor" and a Score 5 stands "extremely foul odor".

  After the first use of the prescribed method by 15 minutes, and after 7 days of use

Secondary Outcomes (2)

• Volatile Sulfur Compound Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect)

  After the first use of the prescribed method by 15 minutes, and after 7 days of use

• Self-assessment of Mouth Odor After 7 Days of Use

  After 7 days of first use

Study Arms (3)

Miswak extract mouth wash

EXPERIMENTAL

50% mouthwash aqueous solution 5ml twice a day for 7 days

Other: Miswak extract mouth wash

Miswak sticks

EXPERIMENTAL

Sticks twice a day for 7 days

Other: Miswak stick

Chlorohexidine gluconate mouth wash

ACTIVE COMPARATOR

0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days

Other: Chlorohexidine gluconate

Interventions

Miswak extract mouth wash OTHER

50% Miswak extract mouth wash (5ml) twice a day for 7 days

Also known as: Salvadora persica mouth wash

Miswak extract mouth wash

Miswak stick OTHER

Miswak stick twice a day for 7 days

Miswak sticks

Chlorohexidine gluconate OTHER

5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days

Also known as: Oraxine ®

Chlorohexidine gluconate mouth wash

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• the participants should report that they suffered from bad oral malodor
• organoleptic score of 2 or above

You may not qualify if:

• smoking
• current systemic diseases or medical treatment
• active caries or any faulty restorations
• acute sinusitis or oro-pharyngeal infection
• chronic periodontitis
• pregnancy
• breast feeding
• eating very spicy food
• use of antibiotic during the last two months before the start of the study

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh colleges of dentistry and pharmacy

Riyadh, Riyadh Region, 11681, Saudi Arabia

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mohammad Rayyan
• Organization: Riyadh Colleges of Dentistry and Pharmacy

mohammadrayyan1979@gmail.com

00966508821318

Study Officials

• Mohammad R Rayyan, MDS

  Assistant professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 11, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 11, 2016
• Results First Posted: May 11, 2016

Record last verified: 2016-04

Locations

SA (1)