Foraminal Enlargement and Postoperative Pain.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.

Detailed Description
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Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.

Official Title
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Influence of Foraminal Enlargement on Postoperative Pain in Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

Conditions
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Pain Postoperative

Intervention / Treatment
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* Procedure: Foraminal enlargement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mature permenent teeth having pulpal necrosis and apical periodontitis. Exclusion Criteria: Systemic disorders Diabetes Pregnancy Less than 18 years of age Immunocompromised Patients who had taken antibiotics in the past 1 month Patients who had a positive history of analgesic use within the past 3 days Previously accessed teeth

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: Intervention<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. Foraminal enlargement will be achieved with #35 K-files in foraminal enlargement group after determining working length. 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. | Procedure: Foraminal enlargement<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.<br>|
| Active Comparator: Control<br>In the control group, no foraminal enlargement will be performed. | Procedure: Foraminal enlargement<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.<br>|

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: 0-3 mild pain, 4-7 moderate pain, and 8-10 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foraminal enlargement, Root canal treatment