Postoperative Pain and PTN and Reciproc

Not Applicable

Completed

• Conditions: Apical Periodontitis; Dental Pulp Necrosis
• Interventions: Procedure: Rotational multi-file system.; Procedure: Reciprocating single-file system

• Registration Number: NCT03380585
• Lead Sponsor: Isparta Military Hospital

Brief Summary

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).

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 Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-02
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProTaper Next	Rotational multi-file system.	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.
Reciproc	Reciprocating single-file system	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.

Primary Outcome Measures

Name	Time	Method
4-step pain intensity measures using a Visual Analog Scale (VAS).	7 days	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.

Secondary Outcome Measures

Name	Time	Method
The number of patients taking an analgesic following the endodontics treatment.	7 days	The patients were asked to take an analgesic in the 7 days of time frame.

Trial Locations

Locations (1)

Isparta Military Hospital; 🇹🇷 Isparta, Turkey