Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems

NCT ID: NCT04454814

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2020-02-15

Brief Summary

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A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.

Detailed Description

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The aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. Root canal treatment was performed in a single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested instrumentation systems, the Mann Whitney test was used. Differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the Friedman test. For the association of pain and an analgesic intake with gender, the chi-square test was performed. For the association of pain with age and an analgesic intake were calculated using Mann Whitney test. A P value \< .05 or less was considered significant.

Conditions

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Asymptomatic Molar Teeth With Periapical Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rotary Engine-driven Instruments

The instrumentation protocol with Protaper Universal rotary files was began with an S1 file with a brushing movement to the two thirds of the working length and then an SX file was introduced to the two thirds of the working length with a brushing movement Afterwards, S1, S2, F1, F2 files in mesial roots and F4 files in distal roots were used to the working length, respectively. Protaper F2 instrument was then used to complete the canal preparation in mesial roots and Protaper F4 instrument was used to complete the canal preparation in distal roots.

Group Type ACTIVE_COMPARATOR

Protaper Universal instruments

Intervention Type OTHER

Root canal treatment using Protaper Universal instruments

Reciprocal Engine-driven Instruments

The instrumentation of the root canal in the Reciproc Blue group began with a R25 instrument with a slow in-and-out pecking movement.According to the manufacturer instructions, a #10 K-file was inserted to the canal to check the canal is free to 1 mm beyond the prepared canal section. After each 3 pecks or when a resistance was encountered the instrument was pulled out of the canal. Afterward, the R25 instrument was inserted in to root canal until approximately two thirds of the working length.RB R25 instrument was then used to complete the canal preparation in mesial roots and RB R40 instrument was used to complete the canal preparation in distal roots.

Group Type ACTIVE_COMPARATOR

Reciproc Blue instruments

Intervention Type OTHER

Root canal treatment using Reciproc Blue instruments

Interventions

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Protaper Universal instruments

Root canal treatment using Protaper Universal instruments

Intervention Type OTHER

Reciproc Blue instruments

Root canal treatment using Reciproc Blue instruments

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients without systemic diseases
* Patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion
* Patients who had no spontaneous pre-treatment pain
* Patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit,
* Patients who had no allergic reaction to NaOCl and no intolerance to nonsteroidal anti-inflammatory drugs.

Exclusion Criteria

* Patients who had severe periodontal disease
* The teeth with previous endodontic treatment
* The teeth with root canal calcification, root resorption
* The teeth that could not be isolated with rubber dam or were not suitable for further restoration
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Gözde Kandemir Demirci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gözde Kandemir Demirci

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Dentistry

Seniha Miçooğulları Kurt

Role: STUDY_CHAIR

Ege University Faculty of Dentistry

Burcu Serefoglu

Role: STUDY_CHAIR

Ege University Faculty of Dentistry

Mehmet E Kaval

Role: STUDY_CHAIR

Ege University Faculty of Dentistry

Mehmet K Çalışkan

Role: STUDY_CHAIR

Ege University Faculty of Dentistry

Locations

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Gözde Kandemir Demirci

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Mollashahi NF, Saberi EA, Havaei SR, Sabeti M. Comparison of Postoperative Pain after Root Canal Preparation with Two Reciprocating and Rotary Single-File Systems: A Randomized Clinical Trial. Iran Endod J. 2017 Winter;12(1):15-19. doi: 10.22037/iej.2017.03.

Reference Type BACKGROUND
PMID: 28179917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27041109 (View on PubMed)

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.

Reference Type RESULT
PMID: 26614017 (View on PubMed)

Gambarini G, Sudani DA, Carlo SD, Pompa G, Pacifici A, Pacifici L, Testarelli L (2013) Incidence and intensivity of postoperative pain and periapical inflammation after endodontic treatment with two different instrumentation techniques. European Journal of Inflammation. 10, 99-103.

Reference Type RESULT

Other Identifiers

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15-6/15

Identifier Type: -

Identifier Source: org_study_id

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