Effectiveness of ChlorohexidineNCT07490873
Antiplaque Efficacy and Patient Reported Outcome of Chlorohexidine, Cetylpyridinium Chloride, and Essential Oil Mouthwashes in Orthodontic Patients
A study testing Chlorohexidine 0.12% mouthwash, Cetylpyridinium chloride 0.05% mouthwash and Essential Oil mouthwash in people with Effectiveness of Chlorohexidine and Effectiveness of Essential Oil, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to evaluate and compare the antiplaque efficacy and patient reported outcome of three commonly used antiseptic mouthwashes - Chlorhexidine (CHX), Cetylpyridinium Chloride (CPC), and Essential Oil (EO) formulations - in orthodontic patients undergoing fixed appliance therapy. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Effectiveness of Chlorohexidine, Effectiveness of Essential Oil, Effectiveness of Cetylpyridinium Chloride
- What is being tested?
- Chlorohexidine 0.12% mouthwash, Cetylpyridinium chloride 0.05% mouthwash and Essential Oil mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 5 Jan 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-30 years.
- Wearing orthometric-type fixed orthodontic appliances(metallic brackets and archwires) and currently in alignment stage.
- Able and willing to attend all study visits and comply with study procedures, including washout periods and mouthwash use.
- Baseline oral status after preparatory phase: plaque index (Löe \& Silness) ≥ 1.0 and gingival index (Löe \& Silness) ≥ 0.5.
- BOP less than 10%.
- Systemically healthy individuals with no history of antibiotic use or other medications in the preceding 3 months.
- Willing to refrain from using any other mouthwash or antimicrobial oral hygiene product (except for the assigned study mouthwash and their routine toothpaste) throughout the study.
- Provide written informed consent (and parental/guardian consent if under legal age).
Who cannot join
- Periodontitis patients and untreated caries requiring urgent care.
- Smoking or use of tobacoo/nicotine products(including vaping).
- Known allergy or hypersensitivity to CHX, CPC, EO components (thymol, eucalyptol, menthol, methyl salicylate), or any ingredient in the study formulations.
- Pregnancy or breastfeeding.
- Use of any antiseptic mouthwash, oral probiotic, or antimicrobial gel in the 3 months prior to baseline.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Dentistry, University of Baghdad
Baghdad, Baghdad Governorate
About this study
Official title: Antiplaque Efficacy and Patient Reported Outcome of Chlorohexidine, Cetylpyridinium Chloride, and Essential Oil Mouthwashes in Orthodontic Patients: A Randomized Crossover Clinical Trial
The goal of this clinical trial is to evaluate and compare the antiplaque efficacy and patient reported outcome of three commonly used antiseptic mouthwashes - Chlorhexidine (CHX), Cetylpyridinium Chloride (CPC), and Essential Oil (EO) formulations - in orthodontic patients undergoing fixed appliance therapy. The main question it aims to answer is:
In orthodontic patients wearing fixed appliances, what is the comparative effect of chlorhexidine, cetylpyridinium chloride, and essential-oil mouthwashes versus placebo on clinical periodontal parameters, salivary IL-1β levels, and patient-reported outcomes.
Read more
Prior to enrollment in the clinical trial, all potential participants will undergo a preparatory phase for one month aimed at achieving optimal oral health and minimizing confounding baseline inflammation. During this phase, participants will receive a full professional oral prophylaxis, including scaling and polishing, to remove dental plaque and calculus deposits. This ensures that all individuals begin the study with a comparable level of oral hygiene and gingival health.
Participants will be instructed on a standardized oral hygiene regimen, including proper toothbrushing technique using a soft-bristled toothbrush and fluoridated toothpaste twice daily. In addition, each participant will be provided with a single-tufted brush as an interproximal cleaning aid to maintain plaque control around orthodontic brackets and hard-to-reach areas. The use of any other mouthwash or adjunctive antimicrobial agent will be prohibited during this phase. After preparatory phase, participants will undergo a four-day plaque-accumulation period immediately prior to baseline clinical and biochemical assessments. During this 4-day period participants will be instructed to refrain from all mechanical oral hygiene procedures (no toothbrushing, interdental cleaning, or mouthrinse use) in order to standardize plaque formation across subjects and create a measurable baseline plaque burden for subsequent comparisons.
After that, In base line visit the salivary sample will be collected for IL-1β measurement and clinical periodontal parameters (PI,GI,BOP,PPD) will be measured and receiving oral hygiene instructions and motivation, and first intervention will be given to the patient.
After one week Saliva will be collected for IL-1β measurement and the clinical measurements ( PI,GI,BOP)will be taken, then the participant goes into washout period for two weeks, after that the participant will be called to repeat the same protocol for the remaining three interventions.
- Conditions
- Effectiveness of Chlorohexidine, Effectiveness of Essential Oil, Effectiveness of Cetylpyridinium Chloride
- Being tested
- Chlorohexidine 0.12% mouthwash, Cetylpyridinium chloride 0.05% mouthwash, Essential Oil mouthwash, Placebo mouthwash
- Keywords
- Chlorohexidine, Cetylpyridinium chloride, Essential oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorohexidine 0.12% mouthwashDrug
Participants will rinse with 15 mL chlorhexidine gluconate 0.12% mouthwash (Kin Gingival) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after rinsing. This intervention is used as an antimicrobial mouthwash to reduce dental plaque and gingival inflammation.
Cetylpyridinium chloride 0.05% mouthwashDrug
Participants will rinse with 15 mL alcohol-free cetylpyridinium chloride (CPC) 0.05% mouthwash (Kin B5) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after use. CPC acts as a quaternary ammonium antimicrobial agent that disrupts bacterial membranes.
Essential Oil mouthwashDrug
Participants will rinse with 15 mL essential oil mouthwash (Listerine) for 30 seconds twice daily for 7 days. Participants will refrain from eating or drinking for 30 minutes after rinsing. Essential oils act by disrupting bacterial cell walls and inhibiting microbial enzyme activity.
Placebo mouthwashOther
Participants will rinse with 15 mL flavored distilled water for 30 seconds twice daily for 7 days. The placebo solution has similar appearance and flavor but contains no active antimicrobial ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Chlorohexidine mouthwash | Experimental | Chlorohexidine 0.12% mouthwash Receives: Drug: Chlorohexidine 0.12% mouthwash |
| Cetylpyridinium chloride mouthwash | Experimental | Cetylpyridinium chloride 0.05% mouthwash Receives: Drug: Cetylpyridinium chloride 0.05% mouthwash |
| Essential oil mouthwash | Experimental | Essential oil mouthwash Receives: Drug: Essential Oil mouthwash |
| Placebo mouthwash | Placebo comparator | Placebo mouthwash Receives: Other: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (PI)
To assess supragingival plaque accumulation around orthodontic brackets before and after each intervention phase, using using Löe and Silness index on four surfaces (mesial, buccal, distal, lingual,). Each surface is normally given a score of 0 to 3 as follows: 0 = no plaque, 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, the plaque may be recognized only by running a probe across the tooth surface, 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye, 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: 10 weeks
Gingival index (GI)
To evaluate gingival inflammation before and after each intervention phase, using Löe and Silness index, each of the four gingival areas of the tooth is given a score from 0 to 3 as follows:
0 = Normal gingiva, 1 = Mild inflammation slight change in color, slight oedema. No bleeding on probing, 2 = Moderate inflammation-redness, oedema and glazing. Bleeding on probing, 3 = Severe inflammation marked redness and oedema, ulceration, tendency to spontaneous bleeding.
Measured: 10 weeks
Salivary interleukin-1 beta (IL-1β) levels
Quantified using an enzyme-linked immunosorbent assay (ELISA) to assess inflammatory response before and after each intervention phase.
Measured: 10 weeks
Secondary outcomes (4)
Bleeding on probing (BOP)
Recorded as the percentage of sites with bleeding within 30 seconds of gentle probing, BOP will be measured by gently inserting the periodontal probe to the depth of the gingival sulcus\ periodontal pocket then removed coronally and waited for 30 seconds to observe the presence of bleeding (0 = no bleeding, 1 = presence of bleeding).
Measured: 10 weeks
Tolerability (VAS) scale
- Visual analog scale(VAS) scores (0-10) for taste acceptability, burning sensation, and mucosal irritation. ( 0 = no means no pain, 10 = worst possible pain).
Measured: 10 weeks
Patient satisfaction (Likert scale)
Assessed via a short-structured questionnaire (Likert-scale format) after each intervention period:
- Very dissatisfied
- Dissatisfied
- Neutral
- Satisfied
- Very satisfied
Measured: 10 weeks
Adverse events
Clinical observation for staining, ulceration, or desquamation.(Yes/NO)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start5 Jan 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of ChlorohexidineStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is 4 arms, randomized, triple-blind, crossover clinical trial conducted among orthodontic patients with fixed appliances.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Saber Yassir Alkhashan, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490873
- Sponsor's protocol ID
- 1110625
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplaque Efficacy and Patient Reported Outcome of Chlorohexidine, Cetylpyridinium Chloride, and Essential Oil Mouthwashes in Orthodontic Patients: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07490873
- Acronym / sponsor ID
- 1110625
- Conditions
- Effectiveness of Chlorohexidine, Effectiveness of Essential Oil, Effectiveness of Cetylpyridinium Chloride
- Keywords
- Chlorohexidine, Cetylpyridinium chloride, Essential oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate and compare the antiplaque efficacy and patient reported outcome of three commonly used antiseptic mouthwashes - Chlorhexidine (CHX), Cetylpyridinium Chloride (CPC), and Essential Oil (EO) formulations - in orthodontic patients undergoing fixed appliance therapy. The main question it aims to answer is:
In orthodontic patients wearing fixed appliances, what is the comparative effect of chlorhexidine, cetylpyridinium chloride, and essential-oil mouthwashes versus placebo on clinical periodontal parameters, salivary IL-1β levels, and patient-reported outcomes.
Prior to enrollment in the clinical trial, all potential participants will undergo a preparatory phase for one month aimed at achieving optimal oral health and minimizing confounding baseline inflammation. During this phase, participants will receive a full professional oral prophylaxis, including scaling and polishing, to remove dental plaque and calculus deposits. This ensures that all individuals begin the study with a comparable level of oral hygiene and gingival health.
Participants will be instructed on a standardized oral hygiene regimen, including proper toothbrushing technique using a soft-bristled toothbrush and fluoridated toothpaste twice daily. In addition, each participant will be provided with a single-tufted brush as an interproximal cleaning aid to maintain plaque control around orthodontic brackets and hard-to-reach areas. The use of any other mouthwash or adjunctive antimicrobial agent will be prohibited during this phase. After preparatory phase, participants will undergo a four-day plaque-accumulation period immediately prior to baseline clinical and biochemical assessments. During this 4-day period participants will be instructed to refrain from all mechanical oral hygiene procedures (no toothbrushing, interdental cleaning, or mouthrinse use) in order to standardize plaque formation across subjects and create a measurable baseline plaque burden for subsequent comparisons.
After that, In base line visit the salivary sample will be collected for IL-1β measurement and clinical periodontal parameters (PI,GI,BOP,PPD) will be measured and receiving oral hygiene instructions and motivation, and first intervention will be given to the patient.
After one week Saliva will be collected for IL-1β measurement and the clinical measurements ( PI,GI,BOP)will be taken, then the participant goes into washout period for two weeks, after that the participant will be called to repeat the same protocol for the remaining three interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study is 4 arms, randomized, triple-blind, crossover clinical trial conducted among orthodontic patients with fixed appliances.
| Arm | Type | Receives |
|---|---|---|
| Chlorohexidine mouthwash | Experimental | Drug: Chlorohexidine 0.12% mouthwashChlorohexidine 0.12% mouthwash |
| Cetylpyridinium chloride mouthwash | Experimental | Drug: Cetylpyridinium chloride 0.05% mouthwashCetylpyridinium chloride 0.05% mouthwash |
| Essential oil mouthwash | Experimental | Drug: Essential Oil mouthwashEssential oil mouthwash |
| Placebo mouthwash | Placebo comparator | Other: Placebo mouthwashPlacebo mouthwash |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 14-30 years.
- Wearing orthometric-type fixed orthodontic appliances(metallic brackets and archwires) and currently in alignment stage.
- Able and willing to attend all study visits and comply with study procedures, including washout periods and mouthwash use.
- Baseline oral status after preparatory phase: plaque index (Löe \& Silness) ≥ 1.0 and gingival index (Löe \& Silness) ≥ 0.5.
- BOP less than 10%.
Key exclusion criteria (5 listed)
- Periodontitis patients and untreated caries requiring urgent care.
- Smoking or use of tobacoo/nicotine products(including vaping).
- Known allergy or hypersensitivity to CHX, CPC, EO components (thymol, eucalyptol, menthol, methyl salicylate), or any ingredient in the study formulations.
- Pregnancy or breastfeeding.
- Use of any antiseptic mouthwash, oral probiotic, or antimicrobial gel in the 3 months prior to baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorohexidine 0.12% mouthwashParticipants will rinse with 15 mL chlorhexidine gluconate 0.12% mouthwash (Kin Gingival) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after rinsing. This intervention is used as an antimicrobial mouthwash to reduce dental plaque and gingival inflammation. | Drug | Chlorohexidine mouthwash |
| Cetylpyridinium chloride 0.05% mouthwashParticipants will rinse with 15 mL alcohol-free cetylpyridinium chloride (CPC) 0.05% mouthwash (Kin B5) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after use. CPC acts as a quaternary ammonium antimicrobial agent that disrupts bacterial membranes. | Drug | Cetylpyridinium chloride mouthwash |
| Essential Oil mouthwashParticipants will rinse with 15 mL essential oil mouthwash (Listerine) for 30 seconds twice daily for 7 days. Participants will refrain from eating or drinking for 30 minutes after rinsing. Essential oils act by disrupting bacterial cell walls and inhibiting microbial enzyme activity. | Drug | Essential oil mouthwash |
| Placebo mouthwashParticipants will rinse with 15 mL flavored distilled water for 30 seconds twice daily for 7 days. The placebo solution has similar appearance and flavor but contains no active antimicrobial ingredients. | Other | Placebo mouthwash |
Primary outcome
Plaque index (PI)
Time frame: 10 weeks
To assess supragingival plaque accumulation around orthodontic brackets before and after each intervention phase, using using Löe and Silness index on four surfaces (mesial, buccal, distal, lingual,). Each surface is normally given a score of 0 to 3 as follows: 0 = no plaque, 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, the plaque may be recognized only by running a probe across the tooth surface, 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye, 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Gingival index (GI)
Time frame: 10 weeks
To evaluate gingival inflammation before and after each intervention phase, using Löe and Silness index, each of the four gingival areas of the tooth is given a score from 0 to 3 as follows: 0 = Normal gingiva, 1 = Mild inflammation slight change in color, slight oedema. No bleeding on probing, 2 = Moderate inflammation-redness, oedema and glazing. Bleeding on probing, 3 = Severe inflammation marked redness and oedema, ulceration, tendency to spontaneous bleeding.
Salivary interleukin-1 beta (IL-1β) levels
Time frame: 10 weeks
Quantified using an enzyme-linked immunosorbent assay (ELISA) to assess inflammatory response before and after each intervention phase.
4 secondary outcomes
Bleeding on probing (BOP)
Time frame: 10 weeks
Tolerability (VAS) scale
Time frame: 10 weeks
Patient satisfaction (Likert scale)
Time frame: 10 weeks
Adverse events
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorohexidine 0.12% mouthwash, Cetylpyridinium chloride 0.05% mouthwash and Essential Oil mouthwash in people with Effectiveness of Chlorohexidine and Effectiveness of Essential Oil, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (PI) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.