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OpenTrials
Completed

NCT Number: NCT02929511

Reciprocation vs Rotational Single-file Systems in Postoperative Pain

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.

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Key information

Conditions

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

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Askeri Hastane

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 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.

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

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.

Other names: Reciproc Blue

Rotational single-file system.

Procedure

The device is moving in continuous rotational. It is a single-fie endodontic file.

Other names: OneShape

Active comparator Protaper multi-file system

Procedure

Primary outcomes

  1. Pain level

    Time frame: 7 days.

    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.

Secondary outcomes

  1. Analgesic usage

    Time frame: 7 days.

    The patients will record the consumption of the analgesic during the 7 days of follow-up.

Sponsors and collaborators

Lead sponsor

Isparta Military Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2016
Registry last updated
Apr 23, 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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