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

NCT04482101 | Unknown

• 1 other identifier: postoperative pain
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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) .

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• intensity of postoperative pain

  48th hours

• intensity of postoperative pain

  72nd hours

• intensity of postoperative pain

  5th day

Study Arms (2)

Ah-Plus sealer

EXPERIMENTAL

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

Endosequence BC sealer

EXPERIMENTAL

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

Interventions

Root canal obturation OTHER

Root canal filling

Also known as: Root canal sealer

Ah-Plus sealer; Endosequence BC sealer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent teeth with fully formed apex
• Teeth with vital pulp
• Teeth with no periapical radiolucency
• Patients having preoperative pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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.

  PMID: 29571915 RESULT

• 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.

  PMID: 30397735 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Root Canal Obturation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry

Study Officials

• Hany Sadek, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Muna Mohamed, master

CONTACT

00201277974490; muna.abubaker@dentisrty.cu.edu.eg

Heba ElAsfouri, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 22, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 22, 2020

Record last verified: 2020-07