Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

The Effect of Three Different Bioceramic-Based Root Canal Sealers on Post-Operative Pain

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Other: Post operative pain assessment after root canal treatment

Detailed Description

This prospective clinical study was reported pain levels experienced after obturation were similar for the different pulp statuses and root canal sealers tested. The participants with single-rooted teeth were included and divided into four groups according to the root canal sealer used. Then, the patients were divided into two subgroups according to pulp vitality. The postobturation pain scores were recorded after obturation on a visual analog scale (VAS) at 6, 12, 24, and 48 hours, and at 7 and 30 days. The level of pain experienced after obturation was similar for all root canal sealers in different pulp statuses. The results of the study showed that the bioceramic-based sealers tested can be used safely in clinical practice in terms of postobturation pain.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kırıkkale, Turkey, 71400
    • Ali Turkyilmaz
  • Kirikkale
    • Yahsihan, Kirikkale, Turkey, 71400
      • Ali Turkyilmaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participates were divided into four experimantal groups according to the root canal sealers; Participates were divided into four experimantal groups.	Other: Post operative pain assessment after root canal treatment; 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
Experimental: Groups were divided into two subgroups to be applied on teeth with pulpitis and apical periodontitis; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain from 6 th hours to 30 days between diffrernt pulp status	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,

Collaborators and Investigators

• Sponsor: Kırıkkale University
• Investigators: Study Director: Ali Turkyilmaz, PhD, Kirikkale University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Root canal sealer; Visual analog scale; Calcium-silicate,; Postobturation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 01.06.2023-07/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The authors of the article could not reach a consensus on this issue.

Drug and device information, study documents

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