Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

Not Applicable

Completed

• Conditions: Postoperative Pain, Acute

• Registration Number: NCT06515756
• Lead Sponsor: Kırıkkale University

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.

Study Timeline

• Study Start: 2023-07-04
• Primary Completion: 2023-11-23
• Study Completion: 2024-02-02
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain from 6 th hours to 30 days between root canal sealers	6, 24, and 72 hours and at 7 and 30 days	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).

Secondary Outcome Measures

Name	Time	Method
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,	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).

Trial Locations

Locations (1)

Ali Turkyilmaz; 🇹🇷 Kırıkkale, Turkey