Reciprocation vs Rotational Single-file Systems in Postoperative Pain

Not Applicable

Completed

• Conditions: Apical Periodontitis; Assessment, Pain; Dental Pulp Necrosis
• Interventions: Procedure: Rotational single-file system.; Procedure: Reciprocating single-file system; Procedure: Active comparator Protaper multi-file system

• Registration Number: NCT02929511
• Lead Sponsor: Isparta Military Hospital

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.

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-11
• Study Start: 2017-01-01
• Status Verified: 2017-03
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-18
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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
OneShape	Rotational 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.
Reciproc Blue	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 Blue single-file system (VDW, Germany). The intervention is root canal treatment with the Reciproc Blue single-file system.
Protaper	Active comparator Protaper multi-file system	As a control group, Protaper (Dentsply, Mailleffer, Switzerland) will be used according to the manufacturer's instruction.

Primary Outcome Measures

Name	Time	Method
Pain level	7 days.	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

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

Trial Locations

Locations (1)

Askeri Hastane; 🇹🇷 Isparta, Turkey