Cotinus Coggygria Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

NCT07254819 | Completed DMC

• 1 other identifier: 680/03.02.2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Appliance Complication; Halitosis

Keywords

halitosis; Cotinus Coggygria; Orthodontic Appliance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Modified plaque index (PI-M)

  baseline

• Modified plaque index (PI-M)

  2 weeks

• Gingival Index (GI)

  baseline

• Gingival Index (GI)

  2 weeks

• Dimethyl Sulfide [ (CH3)2S] Levels

  baseline

Study Arms (2)

Experimental: Experimental group Cotinus Coggygria mouthwash

EXPERIMENTAL

Experimental Group: patients, age 13-18, conventional brackets, Cotinus Coggygria mouthwash 15 patients, with conventional brackets

Dietary Supplement: Cotinus Coggygria mouthwash

Placebo control arm: placebo mouthwash

PLACEBO COMPARATOR

Control Group: patients, age 13-18, conventional brackets, Placebo mouthwash 15 patients, with conventional brackets

Dietary Supplement: Placebo mouthwash

Interventions

Cotinus Coggygria mouthwash DIETARY_SUPPLEMENT

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.

Experimental: Experimental group Cotinus Coggygria mouthwash

Placebo mouthwash DIETARY_SUPPLEMENT

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.

Placebo control arm: placebo mouthwash

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

School of Dentistry

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iosif Sifakakis, Associate Professor

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients will be allocated at a 1:1 ratio between group A (Cotinus Coggygria group) and group B (placebo group), for each sex separately using stratified randomization. Two random sequences of 15 letters (A or B) will be obtained from www.random.org (List Randomizer service), one for males and one for females. Those letters were written on paper and then sealed in opaque envelopes, sequentially numbered from M1 to M15 for males and from F1 to F15 for females respectively. All envelopes were sealed, numbered and stored in a drawer by a person not involved in the study. Every patient enrolled in the study will receive an envelope in a numerical order and their name was written on the envelope. Informed consent will be obtained from parents / legal guardians and written consent upon information and prior to the randomization or application of any procedure obtained from the patients.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This trial is designed as a prospective, randomized, placebo-controlled, double (investigator and patient) blinded study, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of Cotinus Coggygria mouthwash or placebo mouthwash.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 3, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)