An interventional study of laser therapy and Hyaluronic acid group in Apthous Ulcer, sponsored by National Research Centre, Egypt. Not yet recruiting. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by National Research Centre, Egypt · Not applicable, Interventional, and Treatment
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
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:
A) 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).
B) 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
C) 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).
D) 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)
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
This study's planned enrollment of 30 is below the median of 65 across 291 interventional studies indexed under Ulcer.
Browse Ulcer studies →National Research Centre, Egypt is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
diode 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 (Gengigel gel) 4 times daily.
Drug: Hyaluronic acid group
Oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group).
Behavioral: Negative control group
Diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact.
Hyaluronic acid (Gengigel gel) 4 times daily.
oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group).
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
Time frame: 2 weeks
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
Time frame: 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
Time frame: 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)
Time frame: 2 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid
National Research Centre, Egypt