Postoperative Pain and PTN and Reciproc

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380585
• Other study ID #: IAH-4
• Status: Completed
• Phase: N/A
• First received: December 15, 2017
• Last updated: March 9, 2018
• Start date: March 1, 2017
• Est. completion date: March 2, 2018

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2, 2018
• Est. primary completion date: March 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
• Dental Pulp Necrosis
• Necrosis
• Pain, Postoperative
• Periapical Periodontitis
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Isparta Military Hospital	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	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	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