- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04789343
The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment
The Effect of Reciprocating Instrument and Obturation Techniques on Postoperative Pain in Retreatment : A Prospective Clinical Study
Objectives: The aim of this study was to assess postoperative pain in prospective randomized clinical trial comparing Reciproc or hand instrument and also different obturation techniques in one visit of endodontic retreatment.
Conventional root canal treatment was done to 45 patients who needed retreatment. All instruments used in this study are routinely used instrument in endodontic therapy. After completed root canal treatment, the patients asked the intense of post operative pain.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Istanbul, Turquie, 34854
- Marmara University Faculty of Dentistry, Basibuyuk Campus, Maltepe
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients who had previosly done unacceptable root canal treatment on lower premolar or molar with no pain.
No medication should be taken 10 days before treatment for any reason ( such as corticosteroid, antibiotics or analgesic )
Exclusion Criteria:
- age less than 18 or over 65,pregnancy nonrestorable tooth other than lower molar or premolar tooth with more than 4mm periodontal pocket root with broken instrument or any post
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: hand files with lateral condensation technique
Previously done root canal filling removed by hand files (Hedstrom file,VDW, Munich,Germany ) and shaped with the same files and after instrumentation, all canals were filled by AH Plus sealer (Dentsply De Tray, Costanz, Germany) and lateral condensation technique of gutta-percha.
|
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated.
However, in the present study, previously done root canal was retreated.
Usually no anaesthesia was used because all root canals were done before.
So just instrumentation and obturation was done.
|
|
Expérimental: Reciproc instrument with lateral condensation technique
Previous root canal filling removed by Reciproc instrument (VDW ,Munich, Germany )using Endomotor (VDW, Munich, Germany).
After removal, root canal instrumented with the same instrument and obturated using AHPlus sealer with lateral condensation technique of gutta-percha.
|
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated.
However, in the present study, previously done root canal was retreated.
Usually no anaesthesia was used because all root canals were done before.
So just instrumentation and obturation was done.
|
|
Expérimental: Reciporoc instrument with continuous warmed condensation technique
Previous root canal removed by Reciproc instrument using Endomotor, shaped and obturated by AhPlus sealer with continuous gutta-percha technique (Diadent Dia-Duo (Diadent, Chongju, Korea).
|
The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated.
However, in the present study, previously done root canal was retreated.
Usually no anaesthesia was used because all root canals were done before.
So just instrumentation and obturation was done.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post operative pain
Délai: 24 hours.
|
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
|
24 hours.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post operative pain; change is being assessed.
Délai: 48 hours
|
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
|
48 hours
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post operative pain; change is being assessed.
Délai: 72 hours.
|
VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
|
72 hours.
|
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post operative pain; change is being assessed.
Délai: 7 days.
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VRS scale was used to assess the intensity of post operative pain or discomfort( 0: no pain,1:mild pain, no medication (analgegic) is requiered, 2 :moderate pain ,feeling pain but no medication is required, 3: severe pain: feeling pain need to take analgesic
|
7 days.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Hesna Sazak Ovecoglu, DDS, PhD, Marmara University Faculty of Dentistry Department of Endodontics
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- SAG-C-DUP-170419-0144
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
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
produit fabriqué et exporté des États-Unis.
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