Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

NCT ID: NCT06515756

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2024-02-02

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.

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.

Conditions

Postoperative Pain, Acute

Study Design

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

Study Groups

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

Participates were divided into four experimantal groups.

Group Type: EXPERIMENTAL

Post operative pain assessment after root canal treatment

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Post operative pain assessment after root canal treatment

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Ali Turkyilmaz

Asisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Turkyilmaz, PhD

Role: STUDY_DIRECTOR

Kirikkale University, Faculty of Dentistry

Locations

Ali Turkyilmaz

Yahşihan, Kırıkkale, Turkey (Türkiye)

Ali Turkyilmaz

Kırıkkale, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 39523312 (View on PubMed)

Other Identifiers

01.06.2023-07/06

Identifier Type: -

Identifier Source: org_study_id