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Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study

Primary Purpose

Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reciprocating system
Rotational system
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • asymptomatic and non-vital teeth associated with periapical lesions

Exclusion Criteria:

  • vital tooth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Reciprocating system

    Rotational system

    Arm Description

    Waveone root canal instrumentation file

    ProTaper Next root canal instrumentation file

    Outcomes

    Primary Outcome Measures

    4-point pain intensity scale
    Change from intensity of postoperative pain at 48 hours

    Secondary Outcome Measures

    Full Information

    First Posted
    September 30, 2015
    Last Updated
    October 1, 2015
    Sponsor
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02566486
    Brief Title
    Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study
    Official Title
    Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bulent Ecevit University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim The aim of this clinical study was to evaluate the influence of the instrumentation techniques on the incidence and intensity of postoperative pain in single-visit root canal treatment. Methodology Ninety patients with single root/canal and non-vital pulps were included. The patients were assigned into 3 groups according to root canal instrumentation technique used; the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed by 4-point pain intensity scale. All the participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data were analyzed by the Kruskal-Wallis test.
    Detailed Description
    Overall, 90 patients who had asymptomatic and non-vital teeth associated with periapical lesions, were included to the study. All diagnosis and treatment procedures were performed by a single operator to eliminate or minimize individual variability in the treatment between clinicians. The patients were randomly stratified into 3 groups of 30 by coin toss. Allocation was done by a person other than the operator performing the root canal procedure. The patients were assigned into three equal groups according to instrumentation techniques used (n=30); The modified step-back technique (n=30): The canals were instrumented with a modified step-back technique using stainless-steel hand files (HF, Dentsply Maillefer, Ballaigues, Switzerland). The canals were prepared to a master apical size 02/40 with K files by using the balance force technique. Step back technique was performed by using K-files #45-55 to a master apical size 02/40 with K files. The step back technique was performed using K-files #45-55. Reciprocal technique (n=30): The canals were instrumented with a driven reciprocation motion, using WaveOne (WO, Dentsply Maillefer, Ballaigues, Switzerland) file having a size 40 and a taper of 0.06 slow in-and-out pecking motion according to the manufacturer's instructions. The flutes of the instrument were cleaned after 3 pecks. Rotational technique (n=30): The canals were instrumented using ProTaper Next (PTN, Dentsply Maillefer, Ballaigues, Switzerland) 06/40 file in the sequence X1, X2, X3, X4 at a rotational speed of 300 rpm and 200 g/cm torque according to the manufacturer's instructions. The instruments were used up to the working length. After isolation and access cavity preparation, the initial working length was then determined with an electronic root canal measurement device (Root ZX mini; J. Morita, Tokyo, Japan). It was confirmed using periapical radiographs. During the instrumentation, a total of 10 ml of 5% NaOCl were used for irrigation. The irrigation needle (NaviTip 31ga needle; Ultradent, South Jordan, UT, USA) was placed as deep as possible into the canal without resistance until it was 1 mm short of the predetermined WL.The final irrigation was performed with 5% NaOCl, 17% EDTA, and 2% chlorhexidine. The root canals were obturated with gutta-percha and a resin based sealer (AH26, De Trey Dentsply, Konstanz, Germany) using cold lateral compaction technique. A standardized master cone size #40.02 gutta-percha was fitted with tug back at the working length. The gutta-percha cone was lightly coated with sealer and slowly inserted into the canal. Cold lateral compaction with accessory gutta-percha cones size 15 was performed until these could not be introduced more than 5 mm into the root canal. All canals were shaped, cleaned, and obturated in a single-visit. Although no systemic medication was prescribed, the patients were instructed to take mild analgesics (400 mg of ibuprofen), if they experienced pain. The assessment of postoperative pain was carried out at 12, 24, and 48 hours after initial appointment by one independent clinician blinded to the groups. All the participants were called by blinded operator through phone at 12, 24 and 48 h to obtain the pain scores using a 4-point pain intensity scale (Dalton Orstavik et al. 1998). The presence or absence of pain, or the appropriate degree of pain was recorded by using a 4-point pain intensity scale. The pain categories were as follows: no pain; slight pain (mild discomfort, need no treatment); moderate pain (pain relieved by analgesics); severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Reciprocating system
    Arm Type
    Other
    Arm Description
    Waveone root canal instrumentation file
    Arm Title
    Rotational system
    Arm Type
    Other
    Arm Description
    ProTaper Next root canal instrumentation file
    Intervention Type
    Device
    Intervention Name(s)
    Reciprocating system
    Other Intervention Name(s)
    WaveOne
    Intervention Description
    Different root canal instrumentation systems
    Intervention Type
    Device
    Intervention Name(s)
    Rotational system
    Other Intervention Name(s)
    ProTaper Next
    Intervention Description
    Different root canal instrumentation systems
    Primary Outcome Measure Information:
    Title
    4-point pain intensity scale
    Description
    Change from intensity of postoperative pain at 48 hours
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: asymptomatic and non-vital teeth associated with periapical lesions Exclusion Criteria: vital tooth

    12. IPD Sharing Statement

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    Postoperative Pain Intensity After Using Different Instrumentation Techniques: a Randomized Clinical Study

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