Postoperative Pain and PTN and Reciproc

Postoperative Pain Assessment After Foraminal Enlargement Using Protaper Next and Reciproc File Systems.

In this clinical trial, the researchers will investigate the effect of single-file reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper Next) 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) and rotational multi-file system (ProTaper Next).

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Dental Pulp Necrosis
• Intervention / Treatment: Procedure: Reciprocating single-file system; Procedure: Rotational multi-file system.

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 multi-file system. Foraminal enlargement will be perfomed using either Reciproc or ProTaper Next file systems. 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32010
    • Isparta Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reciproc; 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 single-file system. The intervention is foraminal enlargement with the Reciproc single-file system.	Procedure: Reciprocating single-file system; After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.The device in the experimental group moves in CW and CCW direction with different angles. It is a single-file endodontic file system. The intervention is reciprocating single-file system. A Reciproc single-file will be used for enlarging apical foramen. In the active comparator group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.; Other Names: Reciproc
Active Comparator: ProTaper Next; The active comparator is foraminal enlargement with the ProTaper Next multi-file system. Endodontic treatment is identical to experimental group except file systems used. In this group, ProTaper Next multi-file system will be used in enlarging apical foramina.	Procedure: Rotational multi-file system.; After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. In this group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.; Other Names: ProTaper Next

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4-step pain intensity measures using a Visual Analog Scale (VAS).	The severity of pain in 1-7 days according to the VAS: 0 no pain, 1-3 mild pain, 4-7 moderate pain, 7-10 severe pain.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients taking an analgesic following the endodontics treatment.	The patients were asked to take an analgesic in the 7 days of time frame.	7 days

Collaborators and Investigators

• Sponsor: Isparta Military Hospital
• Investigators: Study Director: Ibrahim E YAYLALI, PhD, Isparta Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 2, 2018

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Dental Pulp Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Necrosis; Periapical Periodontitis; Dental Pulp Necrosis
• Other Study ID Numbers: IAH-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No