Postoperative Pain and PTN and Reciproc

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03380585

Enrollment

Registered

2017-12-21

Start date

2017-03-01

Completion date

2018-03-02

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Dental Pulp Necrosis

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.

Interventions

PROCEDUREReciprocating 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.

PROCEDURERotational 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Single-blinded (Participant)

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026