Trial Outcomes & Findings for Effect of Miswak and Miswak Extract on Oral Malodor (NCT NCT02628938)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

212 participants

Primary outcome timeframe

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

Results posted on

2016-05-11

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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	Miswak Sticks Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days	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
Overall Study STARTED	15	15	15
Overall Study COMPLETED	10	13	11
Overall Study NOT COMPLETED	5	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Miswak Sticks Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days	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
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

Effect of Miswak and Miswak Extract on Oral Malodor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Miswak Extract Mouth Wash n=10 Participants 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	Miswak Sticks n=13 Participants Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days	Chlorohexidine Gluconate Mouth Wash n=11 Participants 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	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Self-assessment of mouth odor	3.70 units on a scale STANDARD_DEVIATION 3.33 • n=5 Participants	3.85 units on a scale STANDARD_DEVIATION 1.57 • n=7 Participants	3.91 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	3.83 units on a scale STANDARD_DEVIATION 2.11 • n=4 Participants
Organoleptic scores	2.6 units on a scale STANDARD_DEVIATION 0.84 • n=5 Participants	2.85 units on a scale STANDARD_DEVIATION 0.99 • n=7 Participants	2.45 units on a scale STANDARD_DEVIATION 0.69 • n=5 Participants	2.65 units on a scale STANDARD_DEVIATION 0.85 • n=4 Participants
Volatile sulfur compound	4.3 units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants	3.15 units on a scale STANDARD_DEVIATION 1.21 • n=7 Participants	4.27 units on a scale STANDARD_DEVIATION 0.47 • n=5 Participants	3.85 units on a scale STANDARD_DEVIATION 0.99 • n=4 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Miswak Extract Mouth Wash n=10 Participants 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	Miswak Sticks n=13 Participants Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days	Chlorohexidine Gluconate Mouth Wash n=11 Participants 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
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	1.62 units on a scale Standard Deviation 1.39	1.36 units on a scale Standard Deviation 1.03
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 1.20	0.54 units on a scale Standard Deviation 0.88	1.09 units on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Miswak Extract Mouth Wash n=10 Participants 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	Miswak Sticks n=13 Participants Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days	Chlorohexidine Gluconate Mouth Wash n=11 Participants 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
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	3.38 units on a scale Standard Deviation 0.87	4.09 units on a scale Standard Deviation 0.30
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	3.23 units on a scale Standard Deviation 0.73	4.00 units on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Miswak Extract Mouth Wash n=10 Participants 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	Miswak Sticks n=13 Participants Sticks twice a day for 7 days Miswak stick: Miswak stick twice a day for 7 days	Chlorohexidine Gluconate Mouth Wash n=11 Participants 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
Self-assessment of Mouth Odor After 7 Days of Use	2.00 units on a scale Standard Deviation 2.16	1.92 units on a scale Standard Deviation 1.44	2.18 units on a scale Standard Deviation 0.75

Adverse Events

Miswak Extract Mouth Wash

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Miswak Sticks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorohexidine Gluconate Mouth Wash

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohammad Rayyan

Riyadh Colleges of Dentistry and Pharmacy

Phone: 00966508821318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place