Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems

NCT02940704 | Completed

• 1 other identifier: CEBC-CU-2016-10-145
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Pulpitis

Keywords

Reciproc; One Shape; reciprocation; continuous rotation; irreversible pulpitis; postoperative pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)

  Up to 72 hrs after treatment

Secondary Outcomes (1)

• Number of analgesic tablets taken after endodontic treatment

  up to 72 hours after treatment

Study Arms (2)

Reciproc

EXPERIMENTAL

* Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals. * Size: R40 (40/0.06)

Procedure: Reciproc

One Shape

ACTIVE COMPARATOR

* One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals. * Size: 25/0.06

Procedure: One Shape

Interventions

Reciproc PROCEDURE

* 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.

Reciproc

One Shape PROCEDURE

* Coronal preflaring will be performed using Gates Glidden drill. * Canals will be instrumented using One Shape single-file (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.

One Shape

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Single-rooted mandibular premolar teeth with:
• Preoperative sharp pain.
• Vital response of pulp tissue.
• Normal periapical radiographic appearance or slight widening in lamina dura.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Endodontic Department - Faculty of Oral and Dental Medicine - Cairo University

Cairo, Egypt

Location

Related Publications (11)

• 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.

  PMID: 26843876 BACKGROUND

• 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.

  PMID: 27041109 BACKGROUND

• 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.

  PMID: 21092809 BACKGROUND

• Haapasalo, M. & Shen, Y. Evolution of nickel-titanium instruments: from past to future. Endod. Top. 29, 3-17 (2013).

  BACKGROUND

• 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.

  PMID: 25387860 BACKGROUND

• 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.

  PMID: 26614017 BACKGROUND

• Gambarini, D. G. & Glassman, G. Continuing education TF Adaptive : a novel approach to nickel-titanium instrumentation. Oral Heal. J. (2013).

  BACKGROUND

• 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.

  PMID: 25720984 BACKGROUND

• 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.

  PMID: 23741536 BACKGROUND

• 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.

  PMID: 25773449 BACKGROUND

• 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.

  PMID: 26685850 BACKGROUND

MeSH Terms

Conditions

Pulpitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Michel K Elias, Resident

  Faculty of Oral and Dental Medicine - Cairo University

  PRINCIPAL INVESTIGATOR

• Hebatallah M El-Far, Professor

  Faculty of Oral and Dental Medicine - Cairo University

  STUDY DIRECTOR

• Shaimaa I Gawdat, Lecturer

  Faculty of Oral and Dental Medicine - Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at endodontic department - Faculty of Oral and Dental Medicine- Cairo University

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)