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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03380585
Other study ID # IAH-4
Secondary ID
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
Health authority
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.

Study Design


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
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