Effect of Miswak and Miswak Extract on Oral Malodor
Primary Purpose
Oral Malodor, Halitosis
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Miswak extract mouth wash
Miswak stick
Chlorohexidine gluconate
Sponsored by
About this trial
This is an interventional treatment trial for Oral Malodor focused on measuring Halitosis, Oral Malodor, Miswak, Salvadora Persica
Eligibility Criteria
Inclusion Criteria:
- the participants should report that they suffered from bad oral malodor
- organoleptic score of 2 or above
Exclusion Criteria:
- 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
Sites / Locations
- Riyadh colleges of dentistry and pharmacy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Miswak extract mouth wash
Miswak sticks
Chlorohexidine gluconate mouth wash
Arm Description
50% mouthwash aqueous solution 5ml twice a day for 7 days
Sticks twice a day for 7 days
0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
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)
Scores using breath checker device (Tanita FitScan HC-212SF Breath Checker) were recorded (0=no odor, 1=slight odor, 2=moderate odor, 3=heavy odor, 4=strong odor, 5=intense odor).
Self-assessment of Mouth Odor After 7 Days of Use
Participants were asked to score their own halitosis on a continuous 10-cm visual analogue scale that is marked as "no odor" on the 0-cm end, and as "extremely foul odor" on the 10-cm end
Full Information
NCT ID
NCT02628938
First Posted
December 7, 2015
Last Updated
April 5, 2016
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT02628938
Brief Title
Effect of Miswak and Miswak Extract on Oral Malodor
Official Title
Effect of Miswak and Miswak Extract on Oral Malodor
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
The study was designed as a randomized, parallel group clinical trial with one control and two test groups. The efficacy of each modality was evaluated by comparing the oral malodor indicators before use with those after 15 minutes (masking effect) and 7 days (therapeutic effect) of use. Three indicators for oral malodor were recorded; Organoleptic scores (OLS), Self-assessment of oral malodor, and the level of volatile sulfur compounds (VSC) measured by a breath checker device.
Ethical committee approval was obtained from the research center in Riyadh Colleges of Dentistry and Pharmacy (FUGRP/2013/114) prior to conducting of the study.
Between March and December 2014, screening of volunteered 212 female dental students aged 18-35 years was carried out. Preliminary interview and clinical examinations were done for all volunteers to select the sample according to the study inclusion and exclusion criteria. To be included in the study, the participants should report that they suffered from bad oral malodor and also should have an organoleptic score of 2 or above. Total of 167 interviewed subjects were excluded from the study for not fulfilling the eligibility criteria and a final sample size of 45 volunteers who have satisfied the criteria were selected in the study. The objectives of the study were fully explained and an informed written consent was obtained to participate in the study.
One week before the baseline readings all the 45 participants received instructions to avoid eating spicy foods, garlic and onions 2 days prior to the assessment. All participants were instructed to maintain their current oral hygiene regime.
The included participants (N=45) were randomly divided into 3 groups. (Group ME): 15 participants were asked to rinse with 50% Miswak extract mouth wash (5ml) twice a day for 7 days. Each participant was given a determined volume of the mouth wash and a marked scoop for the prescribed dose. Compliance of the participants was checked by measuring the remaining volume in the bottle during the second visit.
(Group MS): 15 participants were taught and instructed to use Miswak stick twice a day for 7 days. Length of the Miswak stick was measured on the second visit to assess the compliance of the participants in using them.
(Group CH): 15 participants were taught and instructed to rinse with 5 ml of 0.2% Chlorohexidine gluconate mouth wash (Oraxine ®) twice a day for 7 days. Each participant was given a determined volume of the mouth wash and a marked scoop for the prescribed dose. Compliance of the participants was checked by measuring the remaining volume in the bottle during the second visit.
To prepare the Miswak extract, a group of fresh Miswak sticks were collected from the local market and chopped into very small pieces. The sticks were then allowed to dry in room temperature for 2 days before they were ground into powder. To prepare the mouth wash, 10 gm of the powder was added to 100 ml of sterile distilled water and allowed to soak for another two days at a temperature of 4°C. It was then centrifuged for 15 minutes at 2000 rpm and then filtered using 0.45 μm pore size paper. The resultant solution was further diluted by distilled water by the ratio of 1:1 and used within one week.
Measurements of oral malodor indicators:
All readings were taken early in the morning one to three hours after breakfast and tooth brushing. Measurements included the following:
Self-assessment of mouth odor
Organoleptic scores (OLS)
Volatile sulfur compound
Data analysis was performed using paired t-test to compare the different indicator scores before and after the use of each method. One way ANOVA was also performed to test the significance of the difference between the three methods in reducing oral malodor. A P<0.05 was accepted as the level of significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Malodor, Halitosis
Keywords
Halitosis, Oral Malodor, Miswak, Salvadora Persica
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miswak extract mouth wash
Arm Type
Experimental
Arm Description
50% mouthwash aqueous solution 5ml twice a day for 7 days
Arm Title
Miswak sticks
Arm Type
Experimental
Arm Description
Sticks twice a day for 7 days
Arm Title
Chlorohexidine gluconate mouth wash
Arm Type
Active Comparator
Arm Description
0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days
Intervention Type
Other
Intervention Name(s)
Miswak extract mouth wash
Other Intervention Name(s)
Salvadora persica mouth wash
Intervention Description
50% Miswak extract mouth wash (5ml) twice a day for 7 days
Intervention Type
Other
Intervention Name(s)
Miswak stick
Intervention Description
Miswak stick twice a day for 7 days
Intervention Type
Other
Intervention Name(s)
Chlorohexidine gluconate
Other Intervention Name(s)
Oraxine ®
Intervention Description
5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days
Primary Outcome Measure Information:
Title
Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).
Description
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".
Time Frame
After the first use of the prescribed method by 15 minutes, and after 7 days of use
Secondary Outcome Measure Information:
Title
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)
Description
Scores using breath checker device (Tanita FitScan HC-212SF Breath Checker) were recorded (0=no odor, 1=slight odor, 2=moderate odor, 3=heavy odor, 4=strong odor, 5=intense odor).
Time Frame
After the first use of the prescribed method by 15 minutes, and after 7 days of use
Title
Self-assessment of Mouth Odor After 7 Days of Use
Description
Participants were asked to score their own halitosis on a continuous 10-cm visual analogue scale that is marked as "no odor" on the 0-cm end, and as "extremely foul odor" on the 10-cm end
Time Frame
After 7 days of first use
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
the participants should report that they suffered from bad oral malodor
organoleptic score of 2 or above
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad R Rayyan, MDS
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riyadh colleges of dentistry and pharmacy
City
Riyadh
ZIP/Postal Code
11681
Country
Saudi Arabia
12. IPD Sharing Statement
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Effect of Miswak and Miswak Extract on Oral Malodor
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