Reciprocation vs Rotational Single-file Systems in Postoperative Pain

NCT02929511 | Completed DMC

• 1 other identifier: IAH-3
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Apical Periodontitis; Assessment, Pain; Dental Pulp Necrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days.

Secondary Outcomes (1)

• Analgesic usage

  7 days.

Study Arms (3)

Reciproc Blue

EXPERIMENTAL

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.

Procedure: Reciprocating single-file system

OneShape

EXPERIMENTAL

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

Procedure: Rotational single-file system.

Protaper

ACTIVE COMPARATOR

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

Procedure: Active comparator Protaper multi-file system

Interventions

Reciprocating single-file system 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.

Also known as: Reciproc Blue

Reciproc Blue

Rotational single-file system. PROCEDURE

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

Also known as: OneShape

OneShape

Active comparator Protaper multi-file system PROCEDURE

Protaper

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.

Sponsors & Collaborators

• Isparta Military Hospital: lead

Study Sites (1)

Askeri Hastane

Isparta, 32010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes

Study Officials

• Ibrahim E YAYLALI, PhD

  Devlet hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 18, 2018
• Last Updated: April 23, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)