Reciprocation vs Rotational Single-file Systems in Postoperative Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Apical Periodontitis, Assessment, Pain, Dental Pulp Necrosis

Intervention / Treatment
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* Procedure: Reciprocating single-file system
* Procedure: Rotational single-file system.
* Procedure: Active comparator Protaper multi-file system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reciproc Blue<br>Endodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit. In this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc Blue single-file system (VDW, Germany). The intervention is root canal treatment with the Reciproc Blue single-file system. | Procedure: Reciprocating single-file system<br>* 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.<br>* Other names: Reciproc Blue;|
| Experimental: OneShape<br>In this group, OneShape rotational single-file system (Micro Mega, France) will be used as single-file system according to the manufacturer's instruction. | Procedure: Rotational single-file system.<br>* The device is moving in continuous rotational. It is a single-fie endodontic file.<br>* Other names: OneShape;|
| Active Comparator: Protaper<br>As a control group, Protaper (Dentsply, Mailleffer, Switzerland) will be used according to the manufacturer's instruction. | Procedure: Active comparator Protaper multi-file system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | 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. | 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic usage | The patients will record the consumption of the analgesic during the 7 days of follow-up. | 7 days. |