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Effect of Miswak and Miswak Extract on Oral Malodor

Effect of Miswak and Miswak Extract on Oral Malodor

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02628938
Enrollment
212
Registered
2015-12-11
Start date
2014-03-31
Completion date
2014-12-31
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Malodor, Halitosis

Keywords

Halitosis, Oral Malodor, Miswak, Salvadora Persica

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.

Interventions

OTHERMiswak extract mouth wash

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

Miswak stick twice a day for 7 days

OTHERChlorohexidine gluconate

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

Sponsors

Riyadh Colleges of Dentistry and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Organoleptic 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 useThe 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

MeasureTime frameDescription
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 useScores 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 UseAfter 7 days of first useParticipants 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

Countries

Saudi Arabia

Participant flow

Recruitment details

Recruitment took place between March and December 2014 in the dental clinics of Riyadh colleges of Dentistry and Pharmacy

Pre-assignment details

212 female students aged 18-35 were screened. 167 were excluded for not meeting the inclusion criteria. Only 45 were finally enrolled and distributed on the three groups

Participants by arm

ArmCount
Miswak Extract Mouth Wash
50% mouthwash aqueous solution 5ml twice a day for 7 days Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days
10
Miswak Sticks
Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days
13
Chlorohexidine Gluconate Mouth Wash
0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days
11
Total34

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDid not attend the follow up recall221
Overall StudyFailure to comply with the instructions303

Baseline characteristics

CharacteristicMiswak Extract Mouth WashTotalChlorohexidine Gluconate Mouth WashMiswak Sticks
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants34 Participants11 Participants13 Participants
Organoleptic scores2.6 units on a scale
STANDARD_DEVIATION 0.84
2.65 units on a scale
STANDARD_DEVIATION 0.85
2.45 units on a scale
STANDARD_DEVIATION 0.69
2.85 units on a scale
STANDARD_DEVIATION 0.99
Self-assessment of mouth odor3.70 units on a scale
STANDARD_DEVIATION 3.33
3.83 units on a scale
STANDARD_DEVIATION 2.11
3.91 units on a scale
STANDARD_DEVIATION 1.3
3.85 units on a scale
STANDARD_DEVIATION 1.57
Sex: Female, Male
Female
10 Participants34 Participants11 Participants13 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Volatile sulfur compound4.3 units on a scale
STANDARD_DEVIATION 0.48
3.85 units on a scale
STANDARD_DEVIATION 0.99
4.27 units on a scale
STANDARD_DEVIATION 0.47
3.15 units on a scale
STANDARD_DEVIATION 1.21

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Miswak Extract Mouth WashOrganoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).After 15 minutes of first use2.10 units on a scaleStandard Deviation 1.45
Miswak Extract Mouth WashOrganoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).After 7 days of first use1.10 units on a scaleStandard Deviation 1.2
Miswak SticksOrganoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).After 15 minutes of first use1.62 units on a scaleStandard Deviation 1.39
Miswak SticksOrganoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).After 7 days of first use0.54 units on a scaleStandard Deviation 0.88
Chlorohexidine Gluconate Mouth WashOrganoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).After 15 minutes of first use1.36 units on a scaleStandard Deviation 1.03
Chlorohexidine Gluconate Mouth WashOrganoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).After 7 days of first use1.09 units on a scaleStandard Deviation 1.04
Comparison: Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth washp-value: 0.299t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth washp-value: 0.007t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticksp-value: 0.019t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticksp-value: 0t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth washp-value: 0t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth washp-value: 0.001t-test, 2 sided
Secondary

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

Time frame: After 7 days of first use

ArmMeasureValue (MEAN)Dispersion
Miswak Extract Mouth WashSelf-assessment of Mouth Odor After 7 Days of Use2.00 units on a scaleStandard Deviation 2.16
Miswak SticksSelf-assessment of Mouth Odor After 7 Days of Use1.92 units on a scaleStandard Deviation 1.44
Chlorohexidine Gluconate Mouth WashSelf-assessment of Mouth Odor After 7 Days of Use2.18 units on a scaleStandard Deviation 0.75
Comparison: Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth washp-value: 0.008t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticksp-value: 0.001t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth washp-value: 0.02t-test, 2 sided
Secondary

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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Miswak Extract Mouth WashVolatile 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 15 minutes of first use4.00 units on a scaleStandard Deviation 1.25
Miswak Extract Mouth WashVolatile 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 7 days of first use3.80 units on a scaleStandard Deviation 1.32
Miswak SticksVolatile 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 15 minutes of first use3.38 units on a scaleStandard Deviation 0.87
Miswak SticksVolatile 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 7 days of first use3.23 units on a scaleStandard Deviation 0.73
Chlorohexidine Gluconate Mouth WashVolatile 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 15 minutes of first use4.09 units on a scaleStandard Deviation 0.3
Chlorohexidine Gluconate Mouth WashVolatile 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 7 days of first use4.00 units on a scaleStandard Deviation 0.22
Comparison: Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth washp-value: 0.496t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth washp-value: 0.244t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticksp-value: 0.19t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticksp-value: 0.829t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth washp-value: 0.341t-test, 2 sided
Comparison: Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth washp-value: 0.82t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026