Postoperative Pain and PTN and Reciproc

Study Overview
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Brief Summary
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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
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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 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.

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

Conditions
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Apical Periodontitis, Dental Pulp Necrosis

Intervention / Treatment
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* Procedure: Reciprocating single-file system
* Procedure: Rotational 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reciproc<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 single-file system. The intervention is foraminal enlargement with the Reciproc single-file system. | Procedure: Reciprocating single-file system<br>* 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.<br>* Other names: Reciproc;|
| Active Comparator: ProTaper Next<br>The active comparator is foraminal enlargement with the ProTaper Next multi-file system. Endodontic treatment is identical to experimental group except file systems used. In this group, ProTaper Next multi-file system will be used in enlarging apical foramina. | Procedure: Rotational multi-file system.<br>* 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.<br>* Other names: ProTaper Next;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |