Assessment of Postoperative Pain Using Reciproc Versus One Shape Files in Patients With Irreversible Pulpitis

November 2, 2016 updated by: Asmaa Kamal, Cairo University

Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis.

To show whether One Shape rotary system differs from Reciproc reciprocating system in postoperative pain in patients with symptomatic irreversible pulpitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients in the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt.

The dental Unit is Adec 200 U.S.A. The x-ray Machine is ViVi, S.r.I, Italy The x-ray films are Kodac, speed D, size 2. The operator is master degree student in the department of Endodontics. No dental assistant Time: 2016-2017 Diagnosis The diagnostic data will be collected in a case report form by the investigator and confirmed for eligibility with the assistant supervisor and will be enrolled in the study in the same day.

Diagnosis is done by the following:

Recording the chief complaint and history of pain Clinical examination will be evaluated for (sensitivity) of pulp tissues using cold testing (by using Green Endo ice), electric tester.

The patient should experience prolonged response to cold testing and positive response to electric pulp testing Radiographic examination: There should be no periapical radiolucency except for widening periodontal ligaments.

Intervention Full medical and dental history using a schematic dental chart will be obtained from all patients treated during this study. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues using electric pulp tester.

The patients will be randomly divided into 2 group:

Experimental group Reciproc single-file reciprocating instrumentation system. Control group One Shape single-file rotary instrumentation system. Sequence of Procedural steps Preoperative pain will be assessed by 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 bur1.

. The tooth will be properly isolated with rubber dam. Working length will be determined using an electronic apex locator2, and working length will be confirmed by radiograph using K-file3. 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 Reciproc4 reciprocating system set on an electric motor5, with adjusted torque and speed according to the manufacturer's instruction.

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 - Reciproc file selection: R40 (40/0.06) manufacturer.

Control group Coronal preflaring will be performed using Gates Glidden drill. Canals will be instrumented using One Shape1 single-file (25/0.06) set on an electric motor2 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. The rotary files will be introduced inside the canal using EDTA gel3.. Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 11 ml of sterile distilled water using a 27 gauge needle fit to 5ml disposable plastic syringe placed in the canal space without binding

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.

The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.

The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours.

The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.

The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.

Outcomes Primary Outcome :Intensity of postoperative pain will be measured using a numerical rating scale (NRS) immediately after the end of treatment, 6, 12, 24, 48, and 72 hours after the end of endodontic treatment.

The numerical rating scale (0-10 scale) consists of a line anchored by two extremes "0: no pain" and "10: severe pain"; patients will be asked to choose the mark that represents their level of pain from 0 to 10. Pain level will be assigned to one of 4 categorical scores:

0, None; 1, Mild (1-3); 2, Moderate (4-6); 3, Severe (7-10)

0: None

  1. Mild (1-3)
  2. Moderate (4-6)
  3. Severe (7-10)

Secondary outcome Number of analgesic taken by the patient to decrease postoperative pain up to 3 days after the end of endodontic treatment will be recorded by the patient with time intervals.

Participant Timeline:

After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit. At the end of treatment, patients will be asked to record postoperative pain by NRS immediately, then after 6,12,24,48 and 72 hours.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • i. Age 25-45years old. ii. Males or Females. iii. Mandibular premolar teeth with:

    • Single canal
    • 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.
  • A pocket depth greater than 5 mm.
  • Previous endodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reciproc single-file.
The Reciproc is a single-file nickel-titanium systems used in reciprocating motion, made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue .
Procedure: Reciproc single-file
The Reciproc is a single-file nickel-titanium systems , made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue
ACTIVE_COMPARATOR: One Shape single-file .
One Shape is single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue. with electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.
Procedure: One Shape single-file
One Shape is one of the few single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue.In addition to , the electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of pain after endodontic treatment
Time Frame: immediately after the end of treatment up to 72 hours
Intensity of postoperative pain will be measured using a numerical rating scale (NRS)
immediately after the end of treatment up to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of analgesic tablets taken by the patient after endodontic treatment
Time Frame: Within 3 days after endodontic treatment
Within 3 days after endodontic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Shaimaa I Gawdat, Lecturer, Department of endodontics - Faculty of Oral and Dental medicine - CU
  • Principal Investigator: Asmaa M kamel, Student, Department of endodontics - Faculty of Oral and Dental medicine - CU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (ESTIMATE)

November 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • reciproc_one shape

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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