Reciprocation vs Rotational Single-file Systems in Postoperative Pain

Apical Periodontitis Clinical Trial

Official title:

Influence of Reciprocating and Rotational Single-file Systems on the Postoperative Pain: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929511
• Other study ID #: IAH-3
• Status: Completed
• Phase: N/A
• First received: October 7, 2016
• Last updated: April 19, 2018
• Start date: January 1, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: March 2017
• Source: Isparta Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 18, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Assessment, Pain
• Dental Pulp Necrosis
• Necrosis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Reciprocating single-file system
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.
• Rotational single-file system.
The device is moving in continuous rotational. It is a single-fie endodontic file.
• Active comparator Protaper multi-file system

Locations

Country	Name	City	State
Turkey	Askeri Hastane	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Isparta Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analgesic usage	The patients will record the consumption of the analgesic during the 7 days of follow-up.	7 days.