Oral Malodor, Halitosis
Conditions
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
50% Miswak extract mouth wash (5ml) twice a day for 7 days
Miswak stick twice a day for 7 days
5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 use | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | After 7 days of first 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 |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not attend the follow up recall | 2 | 2 | 1 |
| Overall Study | Failure to comply with the instructions | 3 | 0 | 3 |
Baseline characteristics
| Characteristic | Miswak Extract Mouth Wash | Total | Chlorohexidine Gluconate Mouth Wash | Miswak Sticks |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 34 Participants | 11 Participants | 13 Participants |
| Organoleptic scores | 2.6 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 odor | 3.70 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 Participants | 34 Participants | 11 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Volatile sulfur compound | 4.3 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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miswak Extract Mouth Wash | Organoleptic 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 use | 2.10 units on a scale | Standard Deviation 1.45 |
| Miswak Extract Mouth Wash | Organoleptic 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 use | 1.10 units on a scale | Standard Deviation 1.2 |
| Miswak Sticks | Organoleptic 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 use | 1.62 units on a scale | Standard Deviation 1.39 |
| Miswak Sticks | Organoleptic 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 use | 0.54 units on a scale | Standard Deviation 0.88 |
| Chlorohexidine Gluconate Mouth Wash | Organoleptic 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 use | 1.36 units on a scale | Standard Deviation 1.03 |
| Chlorohexidine Gluconate Mouth Wash | Organoleptic 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 use | 1.09 units on a scale | Standard Deviation 1.04 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Miswak Extract Mouth Wash | Self-assessment of Mouth Odor After 7 Days of Use | 2.00 units on a scale | Standard Deviation 2.16 |
| Miswak Sticks | Self-assessment of Mouth Odor After 7 Days of Use | 1.92 units on a scale | Standard Deviation 1.44 |
| Chlorohexidine Gluconate Mouth Wash | Self-assessment of Mouth Odor After 7 Days of Use | 2.18 units on a scale | Standard Deviation 0.75 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miswak Extract Mouth Wash | 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 15 minutes of first use | 4.00 units on a scale | Standard Deviation 1.25 |
| Miswak Extract Mouth Wash | 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 7 days of first use | 3.80 units on a scale | Standard Deviation 1.32 |
| Miswak Sticks | 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 15 minutes of first use | 3.38 units on a scale | Standard Deviation 0.87 |
| Miswak Sticks | 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 7 days of first use | 3.23 units on a scale | Standard Deviation 0.73 |
| Chlorohexidine Gluconate Mouth Wash | 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 15 minutes of first use | 4.09 units on a scale | Standard Deviation 0.3 |
| Chlorohexidine Gluconate Mouth Wash | 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 7 days of first use | 4.00 units on a scale | Standard Deviation 0.22 |