"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
29 avril 2020 mis à jour par: Istanbul Medipol University Hospital
The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation.
The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures.
Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth.
One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied.
The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week.
Postoperative pain will be recorded by each patient by using visual analogue pain scale.
Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants.
The local anesthetic will be applied before the treatment start.
The routine retreatment procedure will be applied.
Different final irrigation solutions will be applied in accordance to the manufacturers' instructions.
At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week.
After one week the teeth will be examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.
Type d'étude
Interventionnel
Inscription (Anticipé)
120
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.
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
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
-Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde retreatment.
Exclusion Criteria:
-The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
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: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at point "0".
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will be opened.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Expérimental: Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Expérimental: Non Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Expérimental: Non Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
Délai: Baseline, 12, 24, 48, 72 hours and 1 week.
|
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale.
Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment.
The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm.
Mild pain was defined as greater than 0 mm and less than or equal to 25 mm.
Mild pain included the descriptors of weak and mild pain.
Moderate pain was defined as greater than 50 mm and less than 75 mm.
Intense pain was defined as equal to or greater than 75 mm.
Intense pain included the descriptors of strong, severe, and maximum possible.
|
Baseline, 12, 24, 48, 72 hours and 1 week.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 (Anticipé)
10 juin 2020
Achèvement primaire (Anticipé)
10 octobre 2020
Achèvement de l'étude (Anticipé)
10 décembre 2021
Dates d'inscription aux études
Première soumission
17 mars 2020
Première soumission répondant aux critères de contrôle qualité
18 mars 2020
Première publication (Réel)
19 mars 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 mai 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 avril 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 224 (registration study)
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
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