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Completed

NCT Number: NCT07254819

Cotinus Coggygria Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

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.

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Key information

Conditions

Orthodontic Appliance Complication Halitosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry

Athens, Attica, 11527, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Hydrogen Sulfide (H2S) Levels

    Time frame: baseline

    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. Hydrogen Sulfide (H2S) Levels

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Modified plaque index (PI-M)

    Time frame: baseline

    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. Modified plaque index (PI-M)

    Time frame: 2 weeks

    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.

  3. Gingival Index (GI)

    Time frame: baseline

    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.

  4. Gingival Index (GI)

    Time frame: 2 weeks

    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.

  5. Dimethyl Sulfide [ (CH3)2S] Levels

    Time frame: baseline

    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.

  6. Dimethyl Sulfide [ (CH3)2S] Levels

    Time frame: 2 weeks

    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.

  7. Methyl-mercaptan (CH3SH) Levels

    Time frame: baseline

    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.

  8. Methyl-mercaptan (CH3SH) Levels

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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