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Oxidative Stress and Antioxidant Responses During Rapid Maxillary Expansion: A Controlled Clinical Study

6 juillet 2026 mis à jour par: Giorgio Gastaldi, IRCCS Ospedale San Raffaele

Rapid maxillary expansion is an orthopedic treatment used to correct transverse maxillary deficiency in growing patients. Mechanical forces generated during expansion may induce local biological responses, including changes in oxidative stress and antioxidant defense mechanisms.

This prospective, non-randomized, controlled pilot study evaluated changes in oxidative and antioxidant biomarkers in gingival crevicular fluid during rapid maxillary expansion and the early retention period. Twenty-eight participants aged 10 to 13 years were included: 14 patients undergoing rapid maxillary expansion and 14 age- and sex-matched untreated controls.

Gingival crevicular fluid samples and periodontal measurements were collected at six corresponding time points. Malondialdehyde, reduced glutathione, glutathione peroxidase, and vitamin C were measured. The study aimed to characterize local biochemical changes associated with the treatment period and to compare their longitudinal patterns with those observed in untreated controls.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

Rapid maxillary expansion is widely used to correct transverse maxillary deficiency in growing patients. Although its skeletal and dentoalveolar effects are well established, the local biochemical responses associated with active expansion and early retention remain incompletely characterized. Mechanical loading may increase the production of reactive oxygen species and alter antioxidant defense mechanisms within periodontal tissues.

The purpose of this study was to evaluate longitudinal changes in oxidative stress and antioxidant biomarkers measured in gingival crevicular fluid during rapid maxillary expansion and to compare these changes with those observed in an untreated control group.

Twenty-eight consecutively recruited orthodontic patients aged 10 to 13 years were included. Fourteen patients with a clinical indication for rapid maxillary expansion formed the intervention group. Fourteen untreated participants, matched by age and sex, formed the control group. Treatment allocation was not randomized because the decision to perform rapid maxillary expansion was based on clinical need.

Participants in the intervention group were treated with a modified Hyrax rapid maxillary expander. The appliance was initially maintained without activation and was subsequently activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the planned expansion was achieved. After active expansion, the screw was stabilized with composite resin and the appliance was maintained as a retention device.

Clinical periodontal assessments and gingival crevicular fluid sampling were performed at six time points: baseline; 24 hours after appliance placement; 7 days after appliance placement during the passive phase; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention. Control participants underwent the same assessment schedule without orthodontic intervention.

Gingival crevicular fluid was analyzed for malondialdehyde, reduced glutathione, glutathione peroxidase activity, and vitamin C. Biomarker values were normalized to total protein concentration. Periodontal measurements included gingival index, plaque index, probing depth, and keratinized tissue percentage.

The study was exploratory and no formal prospective sample size calculation was performed. The findings were intended to characterize local biochemical changes in gingival crevicular fluid and were not designed to provide direct evidence of skeletal or midpalatal suture remodeling.

Type d'étude

Interventionnel

Inscription (Réel)

28

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Age between 10 and 13 years.
  • Good general health.
  • Fully erupted maxillary premolars.
  • Healthy periodontal status, with probing depth of 3 mm or less.
  • For the intervention group, a clinical indication for rapid maxillary expansion.
  • For the control group, no orthodontic treatment planned during the observation period.
  • Ability to comply with the clinical examination and gingival crevicular fluid sampling schedule.
  • Written informed consent from the participant's parent or legal guardian and assent from the participant, where applicable.

Exclusion Criteria:

  • Systemic disease.
  • Current medication use that could influence periodontal, inflammatory, or oxidative status.
  • Active periodontal disease.
  • Probing depth greater than 3 mm.
  • Inability to comply with the oral hygiene protocol or study visits.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: No intervention
Age- and sex-matched participants who did not receive orthodontic treatment during the observation period. Participants underwent the same periodontal examinations and gingival crevicular fluid sampling schedule as the intervention group.
Expérimental: Expansion
A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.
A tooth-borne rapid maxillary expansion appliance with bands cemented to the maxillary permanent first molars and palatal bars connecting the premolar and molar regions to the expansion screw. The screw was activated twice daily, corresponding to approximately 0.5 mm of expansion per day, until the clinically planned expansion was achieved. The screw was subsequently stabilized with composite resin and the appliance was maintained during the retention period.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in gingival crevicular fluid malondialdehyde level
Délai: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Malondialdehyde in gingival crevicular fluid was assessed using a thiobarbituric acid reactive substances method and normalized to total protein concentration. Higher values indicate greater local lipid peroxidation.
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in gingival crevicular fluid reduced glutathione level
Délai: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Reduced glutathione was measured spectrophotometrically and normalized to total protein concentration
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Change in gingival crevicular fluid glutathione peroxidase activity
Délai: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Glutathione peroxidase activity was measured spectrophotometrically and normalized to total protein concentration
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Change in gingival crevicular fluid vitamin C level
Délai: Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.
Vitamin C was measured using a colorimetric spectrophotometric method and normalized to total protein concentration.
Baseline; 24 hours after appliance placement; 7 days after appliance placement; after 7 days of active expansion; after 14 days of active expansion; and after 3 months of retention.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2011

Achèvement primaire (Réel)

31 mai 2011

Achèvement de l'étude (Réel)

30 juin 2012

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

6 juillet 2026

Première publication (Réel)

10 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Oxidative Stress Expansion

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

De-identified individual participant data underlying the published results, together with the data dictionary, may be made available upon reasonable request to the corresponding author and subject to approval by the responsible institution and applicable ethical and data-protection requirements.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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