Apthous UlcerRCTNCT07922681
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
A study testing laser therapy and Hyaluronic acid group in people with Apthous Ulcer, run by National Research Centre, Egypt.
Trial summary
Thirty children with recurrent apthous ulcer will be divided into 3 groups of different treatment modalities to assess their effect on pain, ulcer size, healing and postoperative pain Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Apthous Ulcer
- What is being tested?
- laser therapy and Hyaluronic acid group
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children should be willing to participate in the study.
- Children should have a history of recurrent apthous stomatitis for at least two years with a frequency of at least one outbreak every two months
- Each ulcer had well defined margin for a period less than two days in child complained from pain.
- Each ulcer was in applicable area for easy management.
Who cannot join
- Patients had history of using topical or systemic medication for management of recurrent apthous stomatitis, such as corticosteroid therapy, antibiotics or analgesics during the previous month.
- Patient with special syndrome \& immunological disease where RAS is one of its clinical presentations.
- Patient with allergic conditions
About this study
Official title: Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel: A Randomized Controlled Study
Thirty children with recurrent apthous ulcer will be divided into 3 groups of different treatment modalities to assess their effect on pain, ulcer size, healing and postoperative pain
Read the detailed description
Enrolled children will be randomly allocated to three groups of ten individuals each:
Group one: patients will receive laser therapy with diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact.
Group two: patients will use hyaluronic acid (Gengigel gel) 4 times daily. Group three: patients will receive oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group).
Recruitment of subjects Patients with clinically diagnosed RAS of both sexes with age range between 10-14 years old will be selected from the outpatient clinics of the National Research Centre.
Assessment:
- Assessment of the pain related to the ulcer:
A visual analogue scale (VAS) will be used consisting of a 10-cm horizontal line starting with a pole of no pain to reach the end pole presenting the unbearable pain. Individuals will be requested to mark the point on the horizontal line that best signifies their pain level (Greenberg et al., 2003).
- Assessment of the ulcer sizes:
The ulcer size will be measured by a calibrated periodontal probe, the two dimensions will be calculated to represent the cross-sectional areas of the lesion (Legeret and Furlano, 2021).p13
- Assessment healing by the effectiveness indices (EI) of healing:
The effectiveness indices (EI) of the pain improvement and ulcer size will be analyzed with a formula EI = [(V1 - V4 or V6) ÷ V1] × 100 %] where V4 and V6 referrs to the values which will be measured at day 4 visit and day 6 visit, while V1 referred to the baseline value.
The effectiveness indices will be evaluated on a 4-Rank scale: (Liu et al., 2006).
- Rank (1): Heal: EI ≥ 95%.
- Rank (2): Marked improvement: El < 95%, but ≥ 70%.
- Rank (3): Moderate improvement: EI < 70%, but ≥ 30%.
- Rank (4): No improvement: EI < 30%.
- Assessment of postoperative pain:
A survey questionnaire with ordinal scales will be filled by asking the children at each visit concerning their subjective experience of eating, drinking, and brushing teeth. there will be 4 response alternatives (no, slight, moderate, and severe difficulties)
- Conditions
- Apthous Ulcer
- Being tested
- laser therapy, Hyaluronic acid group, Negative control group
- Keywords
- Apthous ulcer, Diode therapy, Hyaluronic Acid, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyDevice
Diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact.
Hyaluronic acid groupDrug
Hyaluronic acid (Gengigel gel) 4 times daily.
Negative control groupBehavioural
oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group).
| Study group | Role | What they receive |
|---|---|---|
| laser therapy | Experimental | diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. Receives: Device: laser therapy |
| Hyaluronic acid group | Experimental | Hyaluronic acid (Gengigel gel) 4 times daily. Receives: Drug: Hyaluronic acid group |
| Negative control group | Experimental | Oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group). Receives: Behavioral: Negative control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of preoperative pain related to the ulcer
Assessment of the pain related to the ulcer where the unit of measurement is numbers from zero to ten. The measurement tool will be A visual analogue scale (VAS) consisting of a 10-cm horizontal line starting with a pole of no pain (zero) to reach the end pole presenting the unbearable pain (ten). Individuals will be requested to mark the point on the horizontal line that best signifies their pain level
Measured: 2 weeks
Secondary outcomes (3)
Rate of ulcer size reduction
The measurement tool will be the measurement of ulcer size by a calibrated periodontal probe, the two dimensions will be calculated to represent the cross-sectional areas of the lesion, The unit of measurement is millimeter where decreasing in ulcer size represent favorable healing
Measured: 2 weeks
Rate of effectiveness indices (EI) of healing
The measurement tool will be the effectiveness indices (EI) of the pain improvement and ulcer size will be analyzed with a formula EI = [(V1 - V4 or V6) ÷ V1] × 100 %] where V4 and V6 refers to the values which will be measured at day 4 visit and day 6 visit, while V1 referred to the baseline value.
The effectiveness indices will be evaluated on a 4-Rank scale: (Liu et al., 2006).
- Rank (1): Heal: EI ≥ 95%.
- Rank (2): Marked improvement: El < 95%, but ≥ 70%.
- Rank (3): Moderate improvement: EI < 70%, but ≥ 30%.
- Rank (4): No improvement: EI < 30%. The unit of measurement is percentage, calculated from this formula then transformed into numerical ranks
Measured: 2 weeks
Rate of postoperative complications
The measurement tool will be survey questionnaire with ordinal scales will be filled by asking the children at each visit concerning their subjective experience of eating, drinking, and brushing teeth. The unit of measurement will be 4 response alternatives (no, slight, moderate, and severe difficulties)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apthous UlcerStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farouk Rashed, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922681
- Sponsor's protocol ID
- 291020240341
- Acronym
- RCT
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07922681
- Acronym / sponsor ID
- RCT / 291020240341
- Conditions
- Apthous Ulcer
- Keywords
- Apthous ulcer, Diode therapy, Hyaluronic Acid, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Nov 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.
Thirty children with recurrent apthous ulcer will be divided into 3 groups of different treatment modalities to assess their effect on pain, ulcer size, healing and postoperative pain
Detailed description
Enrolled children will be randomly allocated to three groups of ten individuals each:
Group one: patients will receive laser therapy with diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact.
Group two: patients will use hyaluronic acid (Gengigel gel) 4 times daily. Group three: patients will receive oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group).
Recruitment of subjects Patients with clinically diagnosed RAS of both sexes with age range between 10-14 years old will be selected from the outpatient clinics of the National Research Centre.
Assessment:
- Assessment of the pain related to the ulcer:
A visual analogue scale (VAS) will be used consisting of a 10-cm horizontal line starting with a pole of no pain to reach the end pole presenting the unbearable pain. Individuals will be requested to mark the point on the horizontal line that best signifies their pain level (Greenberg et al., 2003).
- Assessment of the ulcer sizes:
The ulcer size will be measured by a calibrated periodontal probe, the two dimensions will be calculated to represent the cross-sectional areas of the lesion (Legeret and Furlano, 2021).p13
- Assessment healing by the effectiveness indices (EI) of healing:
The effectiveness indices (EI) of the pain improvement and ulcer size will be analyzed with a formula EI = [(V1 - V4 or V6) ÷ V1] × 100 %] where V4 and V6 referrs to the values which will be measured at day 4 visit and day 6 visit, while V1 referred to the baseline value.
The effectiveness indices will be evaluated on a 4-Rank scale: (Liu et al., 2006).
- Rank (1): Heal: EI ≥ 95%.
- Rank (2): Marked improvement: El < 95%, but ≥ 70%.
- Rank (3): Moderate improvement: EI < 70%, but ≥ 30%.
- Rank (4): No improvement: EI < 30%.
- Assessment of postoperative pain:
A survey questionnaire with ordinal scales will be filled by asking the children at each visit concerning their subjective experience of eating, drinking, and brushing teeth. there will be 4 response alternatives (no, slight, moderate, and severe difficulties)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laser therapy | Experimental | Device: laser therapydiode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. |
| Hyaluronic acid group | Experimental | Drug: Hyaluronic acid groupHyaluronic acid (Gengigel gel) 4 times daily. |
| Negative control group | Experimental | Behavioral: Negative control groupOral hygiene instructions by avoiding spicy food, cold and hot drinks (control group). |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children should be willing to participate in the study.
- Children should have a history of recurrent apthous stomatitis for at least two years with a frequency of at least one outbreak every two months
- Each ulcer had well defined margin for a period less than two days in child complained from pain.
- Each ulcer was in applicable area for easy management.
Key exclusion criteria (3 listed)
- Patients had history of using topical or systemic medication for management of recurrent apthous stomatitis, such as corticosteroid therapy, antibiotics or analgesics during the previous month.
- Patient with special syndrome \& immunological disease where RAS is one of its clinical presentations.
- Patient with allergic conditions
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 |
|---|---|---|
| laser therapyDiode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. | Device | laser therapy |
| Hyaluronic acid groupHyaluronic acid (Gengigel gel) 4 times daily. | Drug | Hyaluronic acid group |
| Negative control grouporal hygiene instructions by avoiding spicy food, cold and hot drinks (control group). | Behavioural | Negative control group |
Primary outcome
Severity of preoperative pain related to the ulcer
Time frame: 2 weeks
Assessment of the pain related to the ulcer where the unit of measurement is numbers from zero to ten. The measurement tool will be A visual analogue scale (VAS) consisting of a 10-cm horizontal line starting with a pole of no pain (zero) to reach the end pole presenting the unbearable pain (ten). Individuals will be requested to mark the point on the horizontal line that best signifies their pain level
3 secondary outcomes
Rate of ulcer size reduction
Time frame: 2 weeks
Rate of effectiveness indices (EI) of healing
Time frame: 2 weeks
Rate of postoperative complications
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy and Hyaluronic acid group in people with Apthous Ulcer, run by National Research Centre, Egypt.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Severity of preoperative pain related to the ulcer (time frame: 2 weeks). 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 6 Nov 2026.