Reciprocation vs Rotational Single-file Systems in Postoperative Pain

NCT ID: NCT02929511

Last Updated: 2018-04-23

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

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-04-18

Brief Summary

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In this study, the researchers will investigate the effect of single-file reciprocating versus single-file rotational file systems on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc Blue) and rotational single-file system (OneShape). As a reference, Mtwo multi-file (full-sequence) will be used.

Detailed Description

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The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational single-file system. (Reciproc Blue reciprocating single-file system vs OneShape rotational single-file system). The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.

Conditions

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Apical Periodontitis Assessment, Pain Dental Pulp Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Reciproc Blue

Endodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit. In this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc Blue single-file system (VDW, Germany). The intervention is root canal treatment with the Reciproc Blue single-file system.

Group Type EXPERIMENTAL

Reciprocating single-file system

Intervention Type PROCEDURE

The device is moving in CW and CCW direction with different angles. It is a single-file endodontic file. The intervention is Reciproc Blue reciprocating single-file system.

OneShape

In this group, OneShape rotational single-file system (Micro Mega, France) will be used as single-file system according to the manufacturer's instruction.

Group Type EXPERIMENTAL

Rotational single-file system.

Intervention Type PROCEDURE

The device is moving in continuous rotational. It is a single-fie endodontic file.

Protaper

As a control group, Protaper (Dentsply, Mailleffer, Switzerland) will be used according to the manufacturer's instruction.

Group Type ACTIVE_COMPARATOR

Active comparator Protaper multi-file system

Intervention Type PROCEDURE

Interventions

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Reciprocating single-file system

The device is moving in CW and CCW direction with different angles. It is a single-file endodontic file. The intervention is Reciproc Blue reciprocating single-file system.

Intervention Type PROCEDURE

Rotational single-file system.

The device is moving in continuous rotational. It is a single-fie endodontic file.

Intervention Type PROCEDURE

Active comparator Protaper multi-file system

Intervention Type PROCEDURE

Other Intervention Names

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Reciproc Blue OneShape

Eligibility Criteria

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Inclusion Criteria

* Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.

Exclusion Criteria

* Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isparta Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ibrahim E YAYLALI, PhD

Role: PRINCIPAL_INVESTIGATOR

Devlet hastanesi

Locations

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Askeri Hastane

Isparta, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IAH-3

Identifier Type: -

Identifier Source: org_study_id

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