Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT) (RCT)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
- 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%.
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)
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: laser therapy
diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. |
Diode laser 980 nm using a 200 μm fiber optic at a distance of 1-3 mm, with no tissue contact. |
|
Expérimental: Hyaluronic acid group
Hyaluronic acid (Gengigel gel) 4 times daily. |
Hyaluronic acid (Gengigel gel) 4 times daily. |
|
Expérimental: Negative control group
Oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group). |
oral hygiene instructions by avoiding spicy food, cold and hot drinks (control group). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Severity of preoperative pain related to the ulcer
Délai: 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 |
2 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of ulcer size reduction
Délai: 2 weeks
|
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 |
2 weeks
|
|
Rate of effectiveness indices (EI) of healing
Délai: 2 weeks
|
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).
|
2 weeks
|
|
Rate of postoperative complications
Délai: 2 weeks
|
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) |
2 weeks
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 291020240341
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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