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

NCT ID: NCT04482101

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-07-01

Brief Summary

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

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 .

Group Type: EXPERIMENTAL

Root canal obturation

Intervention Type: OTHER

Root canal filling

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 .

Group Type: EXPERIMENTAL

Root canal obturation

Intervention Type: OTHER

Root canal filling

Interventions

Root canal obturation

Root canal filling

Intervention Type: OTHER

Other Intervention Names

Root canal sealer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Muna Abubaker Beshir Mohamed

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany Sadek, PHD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Muna Mohamed, master

Role: CONTACT

muna.abubaker@dentisrty.cu.edu.eg

00201277974490

Heba ElAsfouri, PHD

Role: CONTACT

References

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.

Reference Type: RESULT

PMID: 29571915 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30397735 (View on PubMed)

Other Identifiers

postoperative pain

Identifier Type: -

Identifier Source: org_study_id