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

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

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) .

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Root canal obturation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muna Mohamed, master; Phone Number: 00201277974490; Email: muna.abubaker@dentisrty.cu.edu.eg
• Study Contact Backup: Name: Heba ElAsfouri, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ah-Plus sealer; 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; Root canal filling; Other Names: Root canal sealer
EXPERIMENTAL: Endosequence BC sealer; 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; Root canal filling; Other Names: Root canal sealer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Hany Sadek, PHD, Cairo University

Publications and helpful links

General Publications

• Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
• Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (ACTUAL): July 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: postoperative pain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No