Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

NCT06515756 | Completed

• 1 other identifier: 01.06.2023-07/06
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment. The study tried to answer whether the type of sealer used altered the incidence and intensity of postobturation endodontic pain, whether pulp status affected the incidence and intensity of postobturation endodontic pain and whether there was no difference in analgesic intake by patients after a single-visit root canal treatment between the experimental groups.

Conditions

Postoperative Pain, Acute

Keywords

Calcium-silicate,; Pain; Postobturation; Root canal sealer; Visual analog scale

Outcome Measures

Primary Outcomes (1)

• Change in pain from 6 th hours to 30 days between root canal sealers

  All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10).

  6, 24, and 72 hours and at 7 and 30 days

Secondary Outcomes (1)

• Change in pain from 6 th hours to 30 days between diffrernt pulp status

  6, 24, and 72 hours and at 7 and 30 days,

Study Arms (2)

All participates were divided into four experimantal groups according to the root canal sealers

EXPERIMENTAL

Participates were divided into four experimantal groups.

Other: Post operative pain assessment after root canal treatment

Groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis

EXPERIMENTAL

Four different root canal sealer groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis. Although sealers were different, they was applied with the same technique.

Other: Post operative pain assessment after root canal treatment

Interventions

Post operative pain assessment after root canal treatment OTHER

the sealer was administered to the root canal using the initial paper point and then uniformly distributed using a second paper point before removing any excess sealer with a third paper point. Once the sealer was applied, a single tapered gutta-percha cone was adjusted to fit the root canal. The coronal access cavities were restored with a composite resin material

All participates were divided into four experimantal groups according to the root canal sealers; Groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral hygiene,
• Not reporting pain before the appointment
• Asymptomatic irreversible pulpitis caused by deep carious lesions (vital cases),
• Asymptomatic primary apical periodontitis (non-vital cases).

You may not qualify if:

• Pregnancy,
• Autoimmune diseases,
• Uncontrolled diabetes,
• Smokers,
• Advanced periodontal disease (with 5 mm or more probing depth),
• Patients requiring endodontic treatment for more than one tooth,
• Unrestorable coronal destruction,
• Incomplete root formation, systemic,
• Allergic sensitivity to local anesthetic or NSAIDs.
• ASA II patient
• An analgesic or antibiotic intake the 7 days before the beginning of treatment

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (2)

Ali Turkyilmaz

Yahşihan, Kırıkkale, 71400, Turkey (Türkiye)

Location

Ali Turkyilmaz

Kırıkkale, 71400, Turkey (Türkiye)

Location

Related Publications (1)

• Turkyilmaz A, Baris SD, Hancerliogullari D, Erdemir A. Postobturation Pain of three Novel Calcium Silicate-based sealers with asymptomatic irreversible pulpitis or necrotic pulp with chronic apical periodontitis: prospective clinical trial. BMC Oral Health. 2024 Nov 10;24(1):1366. doi: 10.1186/s12903-024-05161-1.

  PMID: 39523312 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ali Turkyilmaz, PhD

  Kirikkale University, Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were blinded and were unaware of the specific treatment protocol. Participants were then randomly assigned to the four groups in a 1:1 ratio using a computer algorithm program (http:// randomizer.org)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: July 4, 2023
• Primary Completion: November 23, 2023
• Study Completion: February 2, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)