Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers

Study Overview
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Brief Summary
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The aim of this randomized clinical trial was to compare the potential effects of resin-based and bio ceramic sealers on the occurrence and intensity of postoperative pain in patients with asymptomatic apical periodontitis (AAP) .

Detailed Description
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Reports about postoperative pain in endodontics range from 3%-58% in different studies . Pain can be provoked by mechanical, chemical, or microbiological injuries to periodontal tissues . A number of treatment related parameters have been shown to be associated with the presence of postoperative pain, including working length (WL) estimation with an apex locator connected to every file , the number of visits , the choice of instrumentation , and the choice of root canal sealer . Sealers placed in the root canals interfere with periodontal tissues through the apical foramina, lateral canals, or leaching and can potentially affect the healing process in the periodontium. Thus, the local inflammation caused by root canal obturation materials may result in postoperative pain. The intensity of inflammatory reactions depends on a number of different factors, including the composition of the sealer . The use of a sealer during root canal obturation is essential for success of root canal treatment. The sealer has various functions: Attainment of impervious seal Filler for canal irregularities and minor discrepancies between the root canal wall and core-filling material Expressed through lateral or accessory canals Can assist in microbial control Act as lubricant Can have adhesive property to dentin The evolution of newer techniques, instruments, materials, and better understanding of canal anatomy, has changed the face of endodontics completely. One concept that has emerged is the single-visit root canal therapy. Single-visit root canal treatment (RCT) has become a common practice and offers several advantages, including a reduced flare-up rate, decreased number of operative procedures, and no risk of interappointment leakage through temporary restorations. The major consideration regarding one-appointment endodontics has been the concern about postoperative pain . Various studies have evaluated the post-endodontic pain difference between single- and multiple-visit RCT, but most studies have ruled out any significant difference in postoperative pain . It has been suggested that bioceramic materials improve the outcome of endodontic treatment by promoting the differentiation of odontoblasts and by releasing biologically active substances . The bioceramic materials have been shown to be less cytotoxic compared with resin-based AH Plus (Dentsply Maillefer, Ballaigues, Switzerland) in vitro . However, AH Plus (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) exhibited stronger bonding capacity and higher radiopacity compared with bioceramic sealers. The clinical significance of these characteristics is still unclear. Data on the clinical behavior of bioceramic sealers are scarce and of great interest.

Official Title
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Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers : A Randomized Clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: Root canal obturation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent teeth with fully formed apex Teeth with vital pulp Teeth with no periapical radiolucency Patients having preoperative pain Exclusion Criteria: Teeth with incompletely formed apex Teeth requiring secondary endodontic treatment Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients, Patients taking anti-inflammatory or antibiotics Patients giving history of analgesic or antibiotic intake 1 week before treatment Patients below 18 years of age, Patients above 65 years of age Patients having history of peptic ulcer or gastrointestinal bleeding, Teeth having calcified canals, Teeth having multiple canals or multirooted teeth, Teeth affected with periodontal disease. Teeth tender on percussion, Teeth having procedural errors such as transportation, perforation, and missed canals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Ah-Plus sealer<br>Root canal sealer which is a resin-based formula with excellent radiopacity , low shrinkage , low solubility and outstanding flow characteristics . It features a 1:1 , paste-to-paste mixing system for fast , easy preparation and less waste . It is biocompatible and silver free . | Other: Root canal obturation<br>* Root canal filling<br>* Other names: Root canal sealer;|
| Experimental: Endosequence BC sealer<br>It is a root canal sealer which is premixed ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications. It is insoluble , radiopaque and aluminum-free material based on calcium silicate composition , which requires the presence of water to set and hardens . It does not shrink during setting and demonstrate excellent physical properties . | Other: Root canal obturation<br>* Root canal filling<br>* Other names: Root canal sealer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of postoperative pain | Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment | 6th hours | 
| Intensity of postoperative pain | Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment | 12th hours | 
| Intensity of postoperative pain | Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment | 24th hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of postoperative pain | Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment | 48th hours | 
| intensity of postoperative pain | Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment | 72nd hours | 
| intensity of postoperative pain | Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment | 5th day |