Oral MalodorPhase 2NCT02628938
Effect of Miswak and Miswak Extract on Oral Malodor
A Phase 2 study testing Miswak extract mouth wash, Miswak stick and Chlorohexidine gluconate in people with Oral Malodor and Halitosis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor, Halitosis
- What is being tested?
- Miswak extract mouth wash, Miswak stick and Chlorohexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- the participants should report that they suffered from bad oral malodor
- organoleptic score of 2 or above
Who cannot join
- smoking
- current systemic diseases or medical treatment
- active caries or any faulty restorations
- acute sinusitis or oro-pharyngeal infection
- chronic periodontitis
- pregnancy
Show all 9Show fewer
- breast feeding
- eating very spicy food
- use of antibiotic during the last two months before the start of the study
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Riyadh colleges of dentistry and pharmacy
Riyadh, Riyadh Region, 11681
About this study
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
Read the 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.
- Conditions
- Oral Malodor, Halitosis
- Being tested
- Miswak extract mouth wash, Miswak stick, Chlorohexidine gluconate
- Keywords
- Halitosis, Oral Malodor, Miswak, Salvadora Persica
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miswak extract mouth washOther
Also called Salvadora persica mouth wash
50% Miswak extract mouth wash (5ml) twice a day for 7 days
Miswak stickOther
Miswak stick twice a day for 7 days
Chlorohexidine gluconateOther
Also called Oraxine ®
5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Miswak extract mouth wash | Experimental | 50% mouthwash aqueous solution 5ml twice a day for 7 days Receives: Other: Miswak extract mouth wash |
| Miswak sticks | Experimental | Sticks twice a day for 7 days Receives: Other: Miswak stick |
| Chlorohexidine gluconate mouth wash | Active comparator | 0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days Receives: Other: Chlorohexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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)
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).
Measured: 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
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
Measured: After 7 days of first use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral MalodorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ramadan Rayyan, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Mohammad R Rayyan, MDS, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628938
- Sponsor's protocol ID
- FUGRP/2013/114
- Status last verified
- Apr 2016
- First submitted
- 7 Dec 2015
- Last updated
- 11 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Miswak and Miswak Extract on Oral Malodor
- ClinicalTrials.gov ID
- NCT02628938
- Acronym / sponsor ID
- FUGRP/2013/114
- Conditions
- Oral Malodor, Halitosis
- Keywords
- Halitosis, Oral Malodor, Miswak, Salvadora Persica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 11 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Miswak extract mouth wash | Experimental | Other: Miswak extract mouth wash50% mouthwash aqueous solution 5ml twice a day for 7 days |
| Miswak sticks | Experimental | Other: Miswak stickSticks twice a day for 7 days |
| Chlorohexidine gluconate mouth wash | Active comparator | Other: Chlorohexidine gluconate0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- the participants should report that they suffered from bad oral malodor
- organoleptic score of 2 or above
Key exclusion criteria (9 listed)
- smoking
- current systemic diseases or medical treatment
- active caries or any faulty restorations
- acute sinusitis or oro-pharyngeal infection
- chronic periodontitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miswak extract mouth washAlso: Salvadora persica mouth wash50% Miswak extract mouth wash (5ml) twice a day for 7 days | Other | Miswak extract mouth wash |
| Miswak stickMiswak stick twice a day for 7 days | Other | Miswak sticks |
| Chlorohexidine gluconateAlso: Oraxine ®5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days | Other | Chlorohexidine gluconate mouth wash |
Primary outcome
Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).
Time frame: 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".
2 secondary outcomes
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)
Time frame: 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
Time frame: After 7 days of first use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad R Rayyan, MDS principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miswak extract mouth wash, Miswak stick and Chlorohexidine gluconate in people with Oral Malodor and Halitosis, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect). (time frame: After the first use of the prescribed method by 15 minutes, and after 7 days of use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.