Effect of Miswak and Miswak Extract on Oral Malodor

Halitosis Clinical Trial

Official title:

Effect of Miswak and Miswak Extract on Oral Malodor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628938
• Other study ID #: FUGRP/2013/114
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2015
• Last updated: December 11, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical 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

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

Five students from group (A), two of group (B) and 4 of group (C) were excluded due to failure to attend the second visit or failure to comply with the instructions or the prescribed doses. Figure 1 displays the flow diagram of subject enrollment in the study.

Statistical analysis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Halitosis
• Oral Malodor

Intervention

Other:
• Miswak extract mouth wash
50% Miswak extract mouth wash (5ml) twice a day for 7 days
• Miswak stick
Miswak stick twice a day for 7 days
• Chlorohexidine gluconate
5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days

Locations

Country	Name	City	State
Saudi Arabia	Riyadh colleges of dentistry and pharmacy	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline 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".	before the use of the prescribed method (baseline scores), after the first use of the prescribed method by 15 minutes, and after 7 days of use	No
Secondary	Change from baseline 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).	before the use of the prescribed method (baseline scores), after the first use of the prescribed method by 15 minutes, and after 7 days of use	No
Secondary	Change from baseline 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	Self-assessment scores were collected twice; before the use of the prescribed method (baseline scores) and after 7 days of use	No