Cotinus Coggygria Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

The Effect of Cotinus Coggygria Mouthwash on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial

The aim of this trial was to investigate the effect of Cotinus Coggygria mouthwash on halitosis using as proxy the levels of the Volatile Sulfur Compounds (VSCs), and the effect on plaque and gingival indices in adolescents undergoing orthodontic treatment with fixed conventional labial appliances.

Study Overview

• Status: Completed
• Conditions: Halitosis; Orthodontic Appliance Complication
• Intervention / Treatment: Dietary supplement: Cotinus Coggygria mouthwash; Dietary supplement: Placebo mouthwash

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • School of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:

• Age between 13 and 18 years for the group with conventional orthodontic appliances.

This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.

• Good general health.
• Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.
• Total initial VSCs levels above the baseline level of 150ppb.

Exclusion Criteria:

Patients will be excluded for any of the following reasons:

• Active caries
• Periodontitis
• Dental fluorosis / dysplasia of the teeth
• Syndromes, mental disabilities and craniofacial deformities
• Smoking or use of other tobacco products
• Allergy to Cotinus Coggygria (Smoke tree)
• Antibiotics during the last 2 months
• Chlorhexidine or other mouthwash use in the previous 3 weeks
• Participation in other trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Experimental group Cotinus Coggygria mouthwash; Experimental Group: patients, age 13-18, conventional brackets, Cotinus Coggygria mouthwash 15 patients, with conventional brackets	Dietary supplement: Cotinus Coggygria mouthwash; All 30 patients will be randomly assigned to either the Cotinus Coggygria mouthwash group A (Natural Smoke Tree Hydrolina, Ina Essentials) (n = 15) or the placebo Mouthwash group B (from the same manufacturer) (n = 15). All patients will be asked to use the mouthwash twice a day for 14 days and to maintain their usual oral hygiene routine. The measurements will be done in the morning and at least three hours after brushing and without the use of the mouthwash by the participant on the day of the assessments.
Placebo Comparator: Placebo control arm: placebo mouthwash; Control Group: patients, age 13-18, conventional brackets, Placebo mouthwash 15 patients, with conventional brackets	Dietary supplement: Placebo mouthwash; All 30 patients will be randomly assigned to either the group A (Cotinus Coggygria mouthwash ) (n = 15) or the placebo Mouthwash group B (from the same manufacturer) (n = 15). All patients will be asked to use the mouthwash twice a day for 14 days and to maintain their usual oral hygiene routine. The measurements will be done in the morning and at least three hours after brushing and without the use of the mouthwash by the participant on the day of the assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydrogen Sulfide (H2S) Levels	Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.	baseline
Hydrogen Sulfide (H2S) Levels	Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including hydrogen sulfide (H2S). H2S has been linked to increased gingival cell apoptosis and susceptibility to periodontitis.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified plaque index (PI-M)	The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.	2 weeks
Modified plaque index (PI-M)	The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.	baseline
Gingival Index (GI)	The original Silness and Löe Plaque Index (1964) was not designed for orthodontic patients. The present study adopted a widely used modification of this index, in which the teeth are divided into incisal, distal, and mesial areas relative to the bracket, and plaque is graded in each area using values from 0 to 3.	baseline
Gingival Index (GI)	The original Silness and Löe Plaque Index (1964) was not designed for orthodontic patients. The present study adopted a widely used modification of this index, in which the teeth are divided into incisal, distal, and mesial areas relative to the bracket, and plaque is graded in each area using values from 0 to 3.	2 weeks
Dimethyl Sulfide [ (CH3)2S] Levels	Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Dimethyl Sulfide [ (CH3)2S] Levels.	baseline
Dimethyl Sulfide [ (CH3)2S] Levels	Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Dimethyl Sulfide [ (CH3)2S] Levels.	2 weeks
Methyl-mercaptan (CH3SH) Levels	Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Methyl-mercaptan (CH3SH) levels.	baseline
Methyl-mercaptan (CH3SH) Levels	Halitosis can be assessed using Gas chromatography that offers highly accurate qualitative and quantitative analysis of the individual VSCs, making it the preferred method for comprehensive diagnostic evaluation in both routine and complex cases. Halitosis is typically defined by a total VSCs concentration of ⩾150 ppb, a threshold supported across multiple clinical studies. The malodor results from the degradation of organic components in saliva, leading to the production of volatile sulfur compounds (VSCs), including Methyl-mercaptan (CH3SH) levels.	2 weeks

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Study Director: Iosif Sifakakis, Associate Professor, National and Kapodistrian University of Athens, Greece

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Actual): December 17, 2025
• Study Completion (Actual): December 17, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Estimated): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: halitosis; Orthodontic Appliance; Cotinus Coggygria
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Halitosis
• Other Study ID Numbers: 680/03.02.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No