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Cotinus Coggygria Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

N

National and Kapodistrian University of Athens

Status

Completed

Conditions

Halitosis
Orthodontic Appliance Complication

Treatments

Dietary Supplement: Cotinus Coggygria mouthwash
Dietary Supplement: Placebo mouthwash

Study type

Interventional

Funder types

Other

Identifiers

NCT07254819
680/03.02.2025

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

13 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups, including a placebo group

Experimental: Experimental group Cotinus Coggygria mouthwash
Experimental group
Description:
Experimental Group: patients, age 13-18, conventional brackets, Cotinus Coggygria mouthwash 15 patients, with conventional brackets
Treatment:
Dietary Supplement: Cotinus Coggygria mouthwash
Placebo control arm: placebo mouthwash
Placebo Comparator group
Description:
Control Group: patients, age 13-18, conventional brackets, Placebo mouthwash 15 patients, with conventional brackets
Treatment:
Dietary Supplement: Placebo mouthwash

Trial contacts and locations

1

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Central trial contact

Iosif Sifakakis, Associate Professor

Data sourced from clinicaltrials.gov

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