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Completed

NCT Number: NCT03380585

Postoperative Pain and PTN and Reciproc

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).

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Key information

Conditions

Apical Periodontitis Dental Pulp Diseases Dental Pulp Necrosis Jaw Diseases Mouth Diseases Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases Tooth Diseases

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isparta Military Hospital

Isparta, 32010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reciprocating single-file system

Procedure

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.

Other names: Reciproc

Rotational multi-file system.

Procedure

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.

Other names: ProTaper Next

Primary outcomes

  1. 4-step pain intensity measures using a Visual Analog Scale (VAS).

    Time frame: 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 outcomes

  1. The number of patients taking an analgesic following the endodontics treatment.

    Time frame: 7 days

    The patients were asked to take an analgesic in the 7 days of time frame.

Sponsors and collaborators

Lead sponsor

Isparta Military Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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