MedDataX Logo

Cotinus Coggygria Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients

NCT ID: NCT07254819

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2025-12-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthodontic Appliance Complication Halitosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

halitosis Cotinus Coggygria Orthodontic Appliance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Experimental group Cotinus Coggygria mouthwash

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

Group Type EXPERIMENTAL

Cotinus Coggygria mouthwash

Intervention Type 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 control arm: placebo mouthwash

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

Group Type PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Iosif Sifakakis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Iosif Sifakakis, Associate Professor

Role: STUDY_DIRECTOR

National and Kapodistrian University of Athens, Greece

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Dentistry

Athens, Attica, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

680/03.02.2025

Identifier Type: -

Identifier Source: org_study_id