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Reciprocation vs Rotational Single-file Systems in Postoperative Pain

Primary Purpose

Apical Periodontitis, Assessment, Pain, Dental Pulp Necrosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reciprocating single-file system
Rotational single-file system.
Active comparator Protaper multi-file system
Sponsored by
Isparta Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Askeri Hastane

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Reciproc Blue

OneShape

Protaper

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Pain level
A VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.

Secondary Outcome Measures

Analgesic usage
The patients will record the consumption of the analgesic during the 7 days of follow-up.

Full Information

First Posted
October 7, 2016
Last Updated
April 19, 2018
Sponsor
Isparta Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02929511
Brief Title
Reciprocation vs Rotational Single-file Systems in Postoperative Pain
Official Title
Influence of Reciprocating and Rotational Single-file Systems on the Postoperative Pain: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Isparta Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Assessment, Pain, Dental Pulp Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reciproc Blue
Arm Type
Experimental
Arm Description
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.
Arm Title
OneShape
Arm Type
Experimental
Arm Description
In this group, OneShape rotational single-file system (Micro Mega, France) will be used as single-file system according to the manufacturer's instruction.
Arm Title
Protaper
Arm Type
Active Comparator
Arm Description
As a control group, Protaper (Dentsply, Mailleffer, Switzerland) will be used according to the manufacturer's instruction.
Intervention Type
Procedure
Intervention Name(s)
Reciprocating single-file system
Other Intervention Name(s)
Reciproc Blue
Intervention Description
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
Intervention Name(s)
Rotational single-file system.
Other Intervention Name(s)
OneShape
Intervention Description
The device is moving in continuous rotational. It is a single-fie endodontic file.
Intervention Type
Procedure
Intervention Name(s)
Active comparator Protaper multi-file system
Primary Outcome Measure Information:
Title
Pain level
Description
A VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.
Time Frame
7 days.
Secondary Outcome Measure Information:
Title
Analgesic usage
Description
The patients will record the consumption of the analgesic during the 7 days of follow-up.
Time Frame
7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim E YAYLALI, PhD
Organizational Affiliation
Devlet hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Askeri Hastane
City
Isparta
ZIP/Postal Code
32010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Reciprocation vs Rotational Single-file Systems in Postoperative Pain

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