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NCT Number: NCT06515756

Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ali Turkyilmaz, Yahşihan, Kırıkkale, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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