GingivitisNCT07119840
Comparison Of Clinical Effects Of Listerine And Chlorhexidine Mouth Wash In Patients Undergoing Fixed Orthodontic Treatment
A study testing Listerine Mouthwash Product and Chlorhexidine mouthwash in people with Gingivitis and Dental Plaque, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This randomized clinical trial aims to compare the effectiveness of Listerine and Chlorhexidine mouthwashes in improving periodontal health in patients undergoing fixed orthodontic treatment. Gingival Index and Plaque Index will be assessed at baseline, 2 weeks, and 4 weeks. Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Listerine Mouthwash Product and Chlorhexidine mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 30 Dec 2025
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 13-40 years
- Permanent dentition (including first molars)
- Willing to undergo orthodontic treatment and follow instructions
Who cannot join
- Systemic illness (e.g., diabetes, heart disease, hepatitis)
- Pregnant/lactating females
- Tobacco use
- History of allergies to mouthwash/toothpaste
- Use of mouthwash in past 3 months
- Abnormal oral morphology or parafunctional habits
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical trial aims to compare the effectiveness of Listerine and Chlorhexidine mouthwashes in improving periodontal health in patients undergoing fixed orthodontic treatment. Gingival Index and Plaque Index will be assessed at baseline, 2 weeks, and 4 weeks.
Read the detailed description
Orthodontic treatment using fixed appliances can significantly impair oral hygiene due to the presence of brackets, bands, and wires, which create retentive areas that promote plaque accumulation. This buildup can result in gingival inflammation, leading to gingivitis or even periodontitis if not managed effectively. Mechanical plaque control, such as brushing and flossing, is often insufficient under these conditions. Thus, adjunctive chemical plaque control agents like mouthwashes are commonly recommended.
Chlorhexidine (CHX) is widely considered the gold standard for chemical plaque control due to its broad-spectrum antimicrobial activity and prolonged substantivity in the oral cavity. However, CHX is associated with side effects such as tooth staining, altered taste sensation, and mucosal irritation, limiting its long-term use. In contrast, Listerine is a commercially available essential oil-based mouthwash that has demonstrated anti-plaque and anti-inflammatory properties without the same level of side effects.
This double-blind, randomized controlled trial aims to compare the clinical efficacy of CHX (0.12%) and Listerine mouthwash in improving periodontal health among patients undergoing fixed orthodontic treatment. The study will be conducted over a period of 4 weeks at the Orthodontics Department of Saidu College of Dentistry, Swat. A total of 60 participants (30 per group), aged between 13 and 25 years, will be enrolled using non-probability consecutive sampling. Participants will be randomized into two groups using block randomization: one receiving CHX and the other Listerine, both in identical, unlabelled bottles to ensure blinding of both the investigator and participants.
The primary outcome measures are changes in Plaque Index (PI) and Gingival Index (GI), assessed at baseline (Day 0), 2 weeks, and 4 weeks. Oral examinations will be conducted by calibrated examiners using standard indices and WHO probes. Data will be analyzed using R software, with t-tests applied to compare mean scores between groups. Age and gender will be considered as potential effect modifiers.
The study is designed to evaluate whether Listerine, as a more tolerable alternative, provides comparable or superior improvements in periodontal health compared to CHX in orthodontic patients. If proven effective, Listerine may serve as a safer, more acceptable option for long-term use during orthodontic treatment.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Listerine Mouthwash Product, Chlorhexidine mouthwash
- Keywords
- Listerine, Chlorhexidine, Gingival Index, Plaque Index, Oral Hygiene, Orthodontic Appliances
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine Mouthwash ProductDrug
Also called Essential Oil Mouthwash
Participants in this group will receive Listerine mouthwash containing essential oils (menthol, thymol, eucalyptol, and methyl salicylate). They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given.
Chlorhexidine mouthwashDrug
Also called CHX Mouthwash
Participants in this group will receive Chlorhexidine mouthwash at a concentration of 0.12%. They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given.
| Study group | Role | What they receive |
|---|---|---|
| Listerine Group | Experimental | Participants will receive Listerine mouthwash in unlabelled bottles once daily for 4 weeks. Receives: Drug: Listerine Mouthwash Product |
| Chlorhexidine Group | Active comparator | Participants will receive chlorhexidine mouthwash in unlabelled bottles once daily for 4 weeks. Receives: Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index (GI)
Measured using standard GI scale (Grades 0-3)
Measured: baseline, 2 weeks, and 4 weeks , 8 week
Plaque Index (PI)
Measured using Orthodontic Plaque Index (Grades 0-4)
Measured: baseline, 2 weeks, and 4 weeks , 8 week
Secondary outcomes (1)
Side effects
The side effects of the trial will be noted in the adverse event log frame.
Measured: Baseline till 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Aug 2025
- Primary completion29 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, parallel group design where participants are randomly assigned to receive either Chlorhexidine or Listerine mouthwash for 4 weeks. Each participant remains in their assigned intervention group throughout the study without crossover.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Saidu College of Dentistry
- Responsible party
- Sponsor
- Investigators
- Fazli Rabi, MPH*, Principal investigator, Khyber Medical UniversityDr Naveed Sadiq, PhD, Principal investigator, Khyber Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119840
- Sponsor's protocol ID
- KMU/DIR/CTU/2025/005
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non Applicable
Publications
Dehghani M, Abtahi M, Hasanzadeh N, Farahzad Z, Noori M, Noori M. Effect of Propolis mouthwash on plaque and gingival indices over fixed orthodontic patients. J Clin Exp Dent. 2019 Mar 1;11(3):e244-e249. doi: 10.4317/jced.55026. eCollection 2019 Mar.
PubMed 31001394Alavi S, Yaraghi N. The effect of fluoride varnish and chlorhexidine gel on white spots and gingival and plaque indices in fixed orthodontic patients: A placebo-controlled study. Dent Res J (Isfahan). 2018 Jul-Aug;15(4):276-282.
PubMed 30123305Priya BM, Anitha V, Shanmugam M, Ashwath B, Sylva SD, Vigneshwari SK. Efficacy of chlorhexidine and green tea mouthwashes in the management of dental plaque-induced gingivitis: A comparative clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):505-9. doi: 10.4103/0976-237X.169845.
PubMed 26681856Zuttion GS, Juarez HAB, Lima BD, Assumpcao DP, Daneris AP, Tuchtenhagen IH, Casarin M, Muniz FWMG. Comparison of the anti-plaque and anti-gingivitis efficacy of Chlorhexidine and Malva mouthwashes: Randomized crossover clinical trial. J Dent. 2024 Nov;150:105313. doi: 10.1016/j.jdent.2024.105313. Epub 2024 Aug 22.
PubMed 39173823Atassi F, Awartani F. Oral hygiene status among orthodontic patients. J Contemp Dent Pract. 2010 Jul 1;11(4):E025-32.
PubMed 20953561Rabi F, Sadiq N, Jamil M, Samdani SA, Naseem W, Bukhary F, Hussain U, Campobasso A, Pandis N. Comparison of Clinical Effects of Essential Oil-Containing Mouthwash and Chlorhexidine Mouth Wash in Patients Undergoing Fixed Orthodontic Treatment - Three-Month Follow-up Randomized-Controlled Trial. Clin Exp Dent Res. 2026 Oct;12(5):e70477. doi: 10.1002/cre2.70477.
PubMed 42836614
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Clinical Effects Of Listerine And Chlorhexidine Mouth Wash In Patients Undergoing Fixed Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT07119840
- Acronym / sponsor ID
- KMU/DIR/CTU/2025/005
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- Listerine, Chlorhexidine, Gingival Index, Plaque Index, Oral Hygiene, Orthodontic Appliances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Saidu College of Dentistry
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 29 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 13 Aug 2025 (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.
This randomized clinical trial aims to compare the effectiveness of Listerine and Chlorhexidine mouthwashes in improving periodontal health in patients undergoing fixed orthodontic treatment. Gingival Index and Plaque Index will be assessed at baseline, 2 weeks, and 4 weeks.
Detailed description
Orthodontic treatment using fixed appliances can significantly impair oral hygiene due to the presence of brackets, bands, and wires, which create retentive areas that promote plaque accumulation. This buildup can result in gingival inflammation, leading to gingivitis or even periodontitis if not managed effectively. Mechanical plaque control, such as brushing and flossing, is often insufficient under these conditions. Thus, adjunctive chemical plaque control agents like mouthwashes are commonly recommended.
Chlorhexidine (CHX) is widely considered the gold standard for chemical plaque control due to its broad-spectrum antimicrobial activity and prolonged substantivity in the oral cavity. However, CHX is associated with side effects such as tooth staining, altered taste sensation, and mucosal irritation, limiting its long-term use. In contrast, Listerine is a commercially available essential oil-based mouthwash that has demonstrated anti-plaque and anti-inflammatory properties without the same level of side effects.
This double-blind, randomized controlled trial aims to compare the clinical efficacy of CHX (0.12%) and Listerine mouthwash in improving periodontal health among patients undergoing fixed orthodontic treatment. The study will be conducted over a period of 4 weeks at the Orthodontics Department of Saidu College of Dentistry, Swat. A total of 60 participants (30 per group), aged between 13 and 25 years, will be enrolled using non-probability consecutive sampling. Participants will be randomized into two groups using block randomization: one receiving CHX and the other Listerine, both in identical, unlabelled bottles to ensure blinding of both the investigator and participants.
The primary outcome measures are changes in Plaque Index (PI) and Gingival Index (GI), assessed at baseline (Day 0), 2 weeks, and 4 weeks. Oral examinations will be conducted by calibrated examiners using standard indices and WHO probes. Data will be analyzed using R software, with t-tests applied to compare mean scores between groups. Age and gender will be considered as potential effect modifiers.
The study is designed to evaluate whether Listerine, as a more tolerable alternative, provides comparable or superior improvements in periodontal health compared to CHX in orthodontic patients. If proven effective, Listerine may serve as a safer, more acceptable option for long-term use during orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A two-arm, parallel group design where participants are randomly assigned to receive either Chlorhexidine or Listerine mouthwash for 4 weeks. Each participant remains in their assigned intervention group throughout the study without crossover.
| Arm | Type | Receives |
|---|---|---|
| Listerine Group | Experimental | Drug: Listerine Mouthwash ProductParticipants will receive Listerine mouthwash in unlabelled bottles once daily for 4 weeks. |
| Chlorhexidine Group | Active comparator | Drug: Chlorhexidine mouthwashParticipants will receive chlorhexidine mouthwash in unlabelled bottles once daily for 4 weeks. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 13-40 years
- Permanent dentition (including first molars)
- Willing to undergo orthodontic treatment and follow instructions
Key exclusion criteria (6 listed)
- Systemic illness (e.g., diabetes, heart disease, hepatitis)
- Pregnant/lactating females
- Tobacco use
- History of allergies to mouthwash/toothpaste
- Use of mouthwash in past 3 months
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 |
|---|---|---|
| Listerine Mouthwash ProductAlso: Essential Oil MouthwashParticipants in this group will receive Listerine mouthwash containing essential oils (menthol, thymol, eucalyptol, and methyl salicylate). They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given. | Drug | Listerine Group |
| Chlorhexidine mouthwashAlso: CHX MouthwashParticipants in this group will receive Chlorhexidine mouthwash at a concentration of 0.12%. They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given. | Drug | Chlorhexidine Group |
Primary outcome
Gingival Index (GI)
Time frame: baseline, 2 weeks, and 4 weeks , 8 week
Measured using standard GI scale (Grades 0-3)
Plaque Index (PI)
Time frame: baseline, 2 weeks, and 4 weeks , 8 week
Measured using Orthodontic Plaque Index (Grades 0-4)
1 secondary outcome
Side effects
Time frame: Baseline till 8 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 13 Aug 2026.
- Background: PubMed 31001394Dehghani M, Abtahi M, Hasanzadeh N, Farahzad Z, Noori M, Noori M. Effect of Propolis mouthwash on plaque and gingival indices over fixed orthodontic patients. J Clin Exp Dent. 2019 Mar 1;11(3):e244-e249. doi: 10.4317/jced.55026. eCollection 2019 Mar.
- Background: PubMed 30123305Alavi S, Yaraghi N. The effect of fluoride varnish and chlorhexidine gel on white spots and gingival and plaque indices in fixed orthodontic patients: A placebo-controlled study. Dent Res J (Isfahan). 2018 Jul-Aug;15(4):276-282.
- Background: PubMed 26681856Priya BM, Anitha V, Shanmugam M, Ashwath B, Sylva SD, Vigneshwari SK. Efficacy of chlorhexidine and green tea mouthwashes in the management of dental plaque-induced gingivitis: A comparative clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):505-9. doi: 10.4103/0976-237X.169845.
- Background: PubMed 39173823Zuttion GS, Juarez HAB, Lima BD, Assumpcao DP, Daneris AP, Tuchtenhagen IH, Casarin M, Muniz FWMG. Comparison of the anti-plaque and anti-gingivitis efficacy of Chlorhexidine and Malva mouthwashes: Randomized crossover clinical trial. J Dent. 2024 Nov;150:105313. doi: 10.1016/j.jdent.2024.105313. Epub 2024 Aug 22.
- Background: PubMed 20953561Atassi F, Awartani F. Oral hygiene status among orthodontic patients. J Contemp Dent Pract. 2010 Jul 1;11(4):E025-32.
- Derived from this study: PubMed 42836614Rabi F, Sadiq N, Jamil M, Samdani SA, Naseem W, Bukhary F, Hussain U, Campobasso A, Pandis N. Comparison of Clinical Effects of Essential Oil-Containing Mouthwash and Chlorhexidine Mouth Wash in Patients Undergoing Fixed Orthodontic Treatment - Three-Month Follow-up Randomized-Controlled Trial. Clin Exp Dent Res. 2026 Oct;12(5):e70477. doi: 10.1002/cre2.70477.
- Individual participant dataSharing planned: No. Non Applicable
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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.
Fazli Rabi, MPH* principal investigator
Khyber Medical University
Dr Naveed Sadiq, PhD principal investigator
Khyber Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listerine Mouthwash Product and Chlorhexidine mouthwash in people with Gingivitis and Dental Plaque, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 3 inclusion and 6 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 13 Aug 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 Pakistan. 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. 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?
Gingival Index (GI) (time frame: baseline, 2 weeks, and 4 weeks , 8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07119840, which also lists 6 linked publications.
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 13 Aug 2026.