Traumatic Oral UlcerationHYCHO-TOUNCT07709455
Comparison of Hyaluronic Acid and Chlorhexidine Gels for Traumatic Oral Ulcers During Fixed Orthodontic Treatment
A study testing Hyaluronic Acid gel and Chlorhexidine gel in people with Traumatic Oral Ulceration and Orthodontic Treatment, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of topical hyaluronic acid gel and chlorhexidine gel in the management of traumatic oral ulcers that develop following placement of fixed orthodontic appliances. Read more about this study
- Who is it for?
- Ages 13 to 35 years
- Conditions the study is for
- Traumatic Oral Ulceration, Orthodontic Treatment, Orthodontic Appliances, Fixed
- What is being tested?
- Hyaluronic Acid gel and Chlorhexidine gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2026to 28 Jun 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 13 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria Male or female patients aged 13 to 35 years. Patients undergoing treatment with fixed orthodontic appliances. Development of a clinically diagnosed traumatic oral ulcer within the study period following placement or adjustment of fixed orthodontic appliances.
Presentation within 24 hours of ulcer development. Good oral hygiene with no active untreated dental caries. Healthy periodontal condition without clinical signs of gingivitis or periodontitis.
Willingness to comply with the study protocol, attend follow-up visits, and provide written informed consent (or parental/guardian consent for participants younger than 18 years).
Exclusion Criteria Use of medications known to interfere with wound healing, including systemic corticosteroids, immunosuppressive agents, anticoagulants, or chemotherapy.
Current smokers or users of smokeless tobacco products. History of recurrent aphthous stomatitis or other chronic oral ulcerative disorders.
Presence of oral mucosal diseases such as pemphigus vulgaris, bullous disorders, erosive lesions, or oral lichen planus.
Systemic diseases that may impair wound healing or manifest with oral ulceration.
Oral ulcerations of non-traumatic or unknown origin. Known hypersensitivity or allergy to hyaluronic acid, chlorhexidine, or any component of the study gels.
Presence of active oral infection requiring antimicrobial treatment. Inability or unwillingness to comply with study procedures or scheduled follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Hyaluronic Acid Gel and Chlorhexidine Gel in the Treatment of Traumatic Oral Ulcers Following Fixed Orthodontic Appliance Therapy: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of topical hyaluronic acid gel and chlorhexidine gel in the management of traumatic oral ulcers that develop following placement of fixed orthodontic appliances. Traumatic oral ulcers are a common complication of orthodontic treatment and may cause significant pain, discomfort, and difficulty with eating and speaking, potentially affecting patient compliance with treatment.
A total of 30 eligible patients who develop traumatic oral ulcers after placement of fixed orthodontic appliances will be randomly allocated to receive either hyaluronic acid gel or chlorhexidine gel. Participants will be instructed to apply the assigned gel three times daily for seven days. Clinical evaluations will be performed at baseline (Day 1), Day 3, and Day 7 to assess ulcer size and pain intensity using a Visual Analog Scale (VAS). The study will compare changes in pain and ulcer healing between the two treatment groups to determine which gel provides superior clinical outcomes.
Read the detailed description
Traumatic oral ulcers are among the most common adverse effects experienced during fixed orthodontic treatment. They usually occur due to continuous mechanical irritation of the oral mucosa by orthodontic brackets, archwires, or other appliance components. These lesions may cause pain, interfere with mastication and speech, and reduce patient comfort and compliance with orthodontic treatment. Although traumatic ulcers generally heal spontaneously after removal of the source of irritation, topical agents are frequently prescribed to accelerate healing and relieve symptoms.
Hyaluronic acid is a naturally occurring glycosaminoglycan with anti-inflammatory, tissue regenerative, and wound-healing properties. It promotes cell migration, angiogenesis, and extracellular matrix formation, thereby facilitating mucosal repair while reducing pain and inflammation. Chlorhexidine gel is a widely used topical antiseptic that reduces bacterial colonization of oral wounds and helps prevent secondary infection during the healing process. Although both agents are commonly used in dental practice, evidence directly comparing their effectiveness in the management of orthodontic traumatic oral ulcers remains limited.
This study is designed as a single-center, parallel-group, randomized controlled trial conducted in the Department of Orthodontics, DIKIOHS. Thirty patients aged 13-35 years who develop traumatic oral ulcers following placement of fixed orthodontic appliances and meet the eligibility criteria will be enrolled. Participants will be randomly assigned in a 1:1 ratio using the lottery method to receive either topical hyaluronic acid gel or topical chlorhexidine gel.
Participants in both groups will be instructed to apply approximately a grain-sized amount of the assigned gel directly onto the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. They will be advised to avoid eating, drinking, or rinsing immediately after application to maximize contact time with the lesion.
Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. At each visit, ulcer location, clinical appearance, ulcer size (measured in millimeters using a transparent ruler), and pain intensity (measured using a Visual Analog Scale) will be recorded. The primary outcome will be reduction in pain intensity, while secondary outcomes will include reduction in ulcer size and clinical healing over the seven-day treatment period.
The findings of this study are expected to provide evidence regarding the comparative effectiveness of hyaluronic acid gel and chlorhexidine gel for the treatment of traumatic oral ulcers associated with fixed orthodontic appliances. The results may assist orthodontists in selecting the most effective topical treatment to improve patient comfort, promote faster healing, and enhance adherence to orthodontic treatment.
- Conditions
- Traumatic Oral Ulceration, Orthodontic Treatment, Orthodontic Appliances, Fixed, Oral Mucosal Ulceration
- Being tested
- Hyaluronic Acid gel, Chlorhexidine gel
- Keywords
- Oral mucosal ulcer, Fixed orthodontic appliances, Orthodontic treatment, Traumatic oral ulcer, Wound healing
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid gelDrug
Participants assigned to this intervention will apply topical hyaluronic acid gel directly to the traumatic oral ulcer within 24 hours of ulcer development following placement of fixed orthodontic appliances. Approximately a grain-sized amount of the gel will be applied using a clean finger or cotton swab three times daily for seven consecutive days. Participants will be instructed to avoid eating, drinking, or rinsing immediately after application.
Chlorhexidine gelDrug
Participants assigned to this intervention will apply topical chlorhexidine gel directly to the traumatic oral ulcer within 24 hours of ulcer development following placement of fixed orthodontic appliances. Approximately a grain-sized amount of the gel will be applied using a clean finger or cotton swab three times daily for seven consecutive days. Participants will be instructed to avoid eating, drinking, or rinsing immediately after application.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Gel | Experimental | Participants randomized to this arm will receive topical hyaluronic acid gel within 24 hours of developing a traumatic oral ulcer following placement of fixed orthodontic appliances. They will be instructed to apply approximately a grain-sized amount of the gel directly to the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. Receives: Drug: Hyaluronic Acid gel |
| Chlorhexidine Gel | Active comparator | Participants randomized to this arm will receive topical chlorhexidine gel within 24 hours of developing a traumatic oral ulcer following placement of fixed orthodontic appliances. They will be instructed to apply approximately a grain-sized amount of the gel directly to the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. Receives: Drug: Chlorhexidine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Pain intensity associated with traumatic oral ulcers will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded at baseline (Day 1), Day 3, and Day 7 to compare pain reduction between the hyaluronic acid gel and chlorhexidine gel groups.
Measured: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
Secondary outcomes (2)
Change in Ulcer Size
The greatest diameter of the traumatic oral ulcer will be measured in millimeters using a transparent ruler at each follow-up visit. Changes in ulcer size over time will be compared between the treatment groups to evaluate wound healing.
Measured: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
Clinical Healing of Traumatic Oral Ulcers
Clinical healing will be assessed by evaluating the reduction in ulcer size and changes in the clinical appearance of the lesion, including epithelialization, reduction in erythema, and resolution of the ulcer, during the 7-day treatment period.
Measured: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start10 Jan 2026
- Primary completion21 Jun 2026
- Study completion28 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Oral UlcerationStudies 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
- Participants who develop traumatic oral ulcers following placement of fixed orthodontic appliances will be randomly assigned in a 1:1 ratio to receive either topical hyaluronic acid gel or topical chlorhexidine gel. Participants will remain in their assigned treatment group throughout the 7-day follow-up period.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidra Maqbool Ahmed, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709455
- Sponsor's protocol ID
- DIKIOHS-ORTHO-TOU-2026-01
- Acronym
- HYCHO-TOU
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Hyaluronic Acid Gel and Chlorhexidine Gel in the Treatment of Traumatic Oral Ulcers Following Fixed Orthodontic Appliance Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07709455
- Acronym / sponsor ID
- HYCHO-TOU / DIKIOHS-ORTHO-TOU-2026-01
- Conditions
- Traumatic Oral Ulceration, Orthodontic Treatment, Orthodontic Appliances, Fixed, Oral Mucosal Ulceration
- Keywords
- Oral mucosal ulcer, Fixed orthodontic appliances, Orthodontic treatment, Traumatic oral ulcer, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 21 Jun 2026 (actual)
- Study completion
- 28 Jun 2026 (actual)
- First posted
- 16 Jul 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.
This randomized controlled trial aims to compare the effectiveness of topical hyaluronic acid gel and chlorhexidine gel in the management of traumatic oral ulcers that develop following placement of fixed orthodontic appliances. Traumatic oral ulcers are a common complication of orthodontic treatment and may cause significant pain, discomfort, and difficulty with eating and speaking, potentially affecting patient compliance with treatment.
A total of 30 eligible patients who develop traumatic oral ulcers after placement of fixed orthodontic appliances will be randomly allocated to receive either hyaluronic acid gel or chlorhexidine gel. Participants will be instructed to apply the assigned gel three times daily for seven days. Clinical evaluations will be performed at baseline (Day 1), Day 3, and Day 7 to assess ulcer size and pain intensity using a Visual Analog Scale (VAS). The study will compare changes in pain and ulcer healing between the two treatment groups to determine which gel provides superior clinical outcomes.
Detailed description
Traumatic oral ulcers are among the most common adverse effects experienced during fixed orthodontic treatment. They usually occur due to continuous mechanical irritation of the oral mucosa by orthodontic brackets, archwires, or other appliance components. These lesions may cause pain, interfere with mastication and speech, and reduce patient comfort and compliance with orthodontic treatment. Although traumatic ulcers generally heal spontaneously after removal of the source of irritation, topical agents are frequently prescribed to accelerate healing and relieve symptoms.
Hyaluronic acid is a naturally occurring glycosaminoglycan with anti-inflammatory, tissue regenerative, and wound-healing properties. It promotes cell migration, angiogenesis, and extracellular matrix formation, thereby facilitating mucosal repair while reducing pain and inflammation. Chlorhexidine gel is a widely used topical antiseptic that reduces bacterial colonization of oral wounds and helps prevent secondary infection during the healing process. Although both agents are commonly used in dental practice, evidence directly comparing their effectiveness in the management of orthodontic traumatic oral ulcers remains limited.
This study is designed as a single-center, parallel-group, randomized controlled trial conducted in the Department of Orthodontics, DIKIOHS. Thirty patients aged 13-35 years who develop traumatic oral ulcers following placement of fixed orthodontic appliances and meet the eligibility criteria will be enrolled. Participants will be randomly assigned in a 1:1 ratio using the lottery method to receive either topical hyaluronic acid gel or topical chlorhexidine gel.
Participants in both groups will be instructed to apply approximately a grain-sized amount of the assigned gel directly onto the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. They will be advised to avoid eating, drinking, or rinsing immediately after application to maximize contact time with the lesion.
Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. At each visit, ulcer location, clinical appearance, ulcer size (measured in millimeters using a transparent ruler), and pain intensity (measured using a Visual Analog Scale) will be recorded. The primary outcome will be reduction in pain intensity, while secondary outcomes will include reduction in ulcer size and clinical healing over the seven-day treatment period.
The findings of this study are expected to provide evidence regarding the comparative effectiveness of hyaluronic acid gel and chlorhexidine gel for the treatment of traumatic oral ulcers associated with fixed orthodontic appliances. The results may assist orthodontists in selecting the most effective topical treatment to improve patient comfort, promote faster healing, and enhance adherence to orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who develop traumatic oral ulcers following placement of fixed orthodontic appliances will be randomly assigned in a 1:1 ratio to receive either topical hyaluronic acid gel or topical chlorhexidine gel. Participants will remain in their assigned treatment group throughout the 7-day follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Gel | Experimental | Drug: Hyaluronic Acid gelParticipants randomized to this arm will receive topical hyaluronic acid gel within 24 hours of developing a traumatic oral ulcer following placement of fixed orthodontic appliances. They will be instructed to apply approximately a grain-sized amount of the gel directly to the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. |
| Chlorhexidine Gel | Active comparator | Drug: Chlorhexidine gelParticipants randomized to this arm will receive topical chlorhexidine gel within 24 hours of developing a traumatic oral ulcer following placement of fixed orthodontic appliances. They will be instructed to apply approximately a grain-sized amount of the gel directly to the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Hyaluronic Acid gelParticipants assigned to this intervention will apply topical hyaluronic acid gel directly to the traumatic oral ulcer within 24 hours of ulcer development following placement of fixed orthodontic appliances. Approximately a grain-sized amount of the gel will be applied using a clean finger or cotton swab three times daily for seven consecutive days. Participants will be instructed to avoid eating, drinking, or rinsing immediately after application. | Drug | Hyaluronic Acid Gel |
| Chlorhexidine gelParticipants assigned to this intervention will apply topical chlorhexidine gel directly to the traumatic oral ulcer within 24 hours of ulcer development following placement of fixed orthodontic appliances. Approximately a grain-sized amount of the gel will be applied using a clean finger or cotton swab three times daily for seven consecutive days. Participants will be instructed to avoid eating, drinking, or rinsing immediately after application. | Drug | Chlorhexidine Gel |
Primary outcome
Change in Pain Intensity
Time frame: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
Pain intensity associated with traumatic oral ulcers will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded at baseline (Day 1), Day 3, and Day 7 to compare pain reduction between the hyaluronic acid gel and chlorhexidine gel groups.
2 secondary outcomes
Change in Ulcer Size
Time frame: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
Clinical Healing of Traumatic Oral Ulcers
Time frame: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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 Hyaluronic Acid gel and Chlorhexidine gel in people with Traumatic Oral Ulceration and Orthodontic Treatment, run by Dow University of Health Sciences 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?
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 16 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 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?
Change in Pain Intensity (time frame: Baseline (Day 1), Day 3, and Day 7 after initiation of treatment). 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 16 Jul 2026.