Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems
25 juillet 2018 mis à jour par: Michel Karam Eissa Elias, Cairo University
Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I)
- The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis.
- Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
- Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues.
The patients will be randomly divided into 2 groups:
- Experimental group: Reciproc reciprocating instrumentation system.
Control group: One Shape rotary instrumentation system.
- Sequence of Procedural steps
- Preoperative pain will be assessed by Numerical Rating Scale (NRS) before administration of anesthesia.
- Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline).
- An access cavity will be performed using round bur and Endo-Z bur.
- The tooth will be properly isolated with rubber dam.
- Working length will be determined using an electronic apex locator, and working length will be confirmed by radiograph using K-file. Then the working length will be established at 0.5 mm up to the radiographic apex.
- Canals will be explored with hand K-file ISO sizes 10, 15, 20.
- Mechanical preparation for both groups will be as follows:
Experimental group:
- Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
- There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
- Reciproc file selection: R40 (40/0.06) is to be used.
Control group:
- Coronal preflaring will be performed using Gates Glidden drill.
- Canals will be instrumented using One Shape (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.
For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used.
8.The rotary files will be introduced inside the canal using EDTA gel. 9.Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27-gauge needle fit to 5 ml disposable plastic syringe placed as far as possible in the canal space without binding.
10.Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer.
11.The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.
12.The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.
13.The patient will be instructed to take one tablet 400 mg Ibuprofen if he/she experiences severe pain.
Type d'étude
Interventionnel
Inscription (Réel)
54
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
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Cairo, Egypte
- Endodontic Department - Faculty of Oral and Dental Medicine - Cairo University
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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
25 ans à 45 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Single-rooted mandibular premolar teeth with:
- Preoperative sharp pain.
- Vital response of pulp tissue.
- Normal periapical radiographic appearance or slight widening in lamina dura.
Exclusion Criteria:
i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.
vi. Patients having bruxism or clenching. vii. Teeth that have:
- Non vital pulp tissues.
- Association with swelling or fistulous tract.
- Pocket depth greater than 5 mm.
- Previous endodontic treatment.
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: Reciproc
|
|
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Comparateur actif: One Shape
|
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
postoperative pain
Délai: Up to 72 hrs after treatment
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Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)
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Up to 72 hrs after treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of analgesic tablets taken after endodontic treatment
Délai: up to 72 hours after treatment
|
One tablet 400 mg Ibuprofen if patient experiences severe pain after treatment
|
up to 72 hours after treatment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Michel K Elias, Resident, Faculty of oral and dental medicine - cairo university
- Directeur d'études: Hebatallah M El-Far, Professor, Faculty of oral and dental medicine - cairo university
- Chaise d'étude: Shaimaa I Gawdat, Lecturer, Faculty of oral and dental medicine - cairo university
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Shahi S, Asghari V, Rahimi S, Lotfi M, Samiei M, Yavari H, Shakouie S, Nezafati S. Postoperative Pain after Endodontic Treatment of Asymptomatic Teeth Using Rotary Instruments: A Randomized Clinical Trial. Iran Endod J. 2016 Winter;11(1):38-43. doi: 10.7508/iej.2016.01.008. Epub 2015 Dec 24.
- Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
- Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.
- Haapasalo, M. & Shen, Y. Evolution of nickel-titanium instruments: from past to future. Endod. Top. 29, 3-17 (2013).
- Kucukyilmaz E, Savas S, Saygili G, Uysal B. Assessment of apically extruded debris and irrigant produced by different nickel-titanium instrument systems. Braz Oral Res. 2015;29:1-6. doi: 10.1590/1807-3107bor-2015.vol29.0002. Epub 2014 Nov 11.
- Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
- Gambarini, D. G. & Glassman, G. Continuing education TF Adaptive : a novel approach to nickel-titanium instrumentation. Oral Heal. J. (2013).
- Nekoofar MH, Sheykhrezae MS, Meraji N, Jamee A, Shirvani A, Jamee J, Dummer PM. Comparison of the effect of root canal preparation by using WaveOne and ProTaper on postoperative pain: a randomized clinical trial. J Endod. 2015 May;41(5):575-8. doi: 10.1016/j.joen.2014.12.026. Epub 2015 Feb 24.
- Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
- Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.
- Relvas JB, Bastos MM, Marques AA, Garrido AD, Sponchiado EC Jr. Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):1987-1993. doi: 10.1007/s00784-015-1692-0. Epub 2015 Dec 19. Erratum In: Clin Oral Investig. 2016 Nov;20(8):1995.
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 novembre 2016
Achèvement primaire (Réel)
1 mai 2017
Achèvement de l'étude (Réel)
1 janvier 2018
Dates d'inscription aux études
Première soumission
18 octobre 2016
Première soumission répondant aux critères de contrôle qualité
19 octobre 2016
Première publication (Estimation)
21 octobre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juillet 2018
Dernière vérification
1 juillet 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CEBC-CU-2016-10-145
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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