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Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06515756
Enrollment
120
Registered
2024-07-23
Start date
2023-07-04
Completion date
2024-02-02
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Acute

Keywords

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

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.

Interventions

OTHERPost 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

Sponsors

Kırıkkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Masking description

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain from 6 th hours to 30 days between root canal sealers6, 24, and 72 hours and at 7 and 30 daysAll 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

MeasureTime frameDescription
Change in pain from 6 th hours to 30 days between diffrernt pulp status6, 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026