Clinical trial NCT06515756: Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers
Official title: The Effect of Three Different Bioceramic-Based Root Canal Sealers on Post-Operative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Keywords: Calcium-silicate,
Pain
Postobturation
Root canal sealer
Visual analog scale
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in pain from 6 th hours to 30 days between root canal sealers
timeFrame: 6, 24, and 72 hours and at 7 and 30 days
Secondary outcomes:
measure: Change in pain from 6 th hours to 30 days between diffrernt pulp status
timeFrame: 6, 24, and 72 hours and at 7 and 30 days,
Other outcomes:
Locations:
city: Yahsihan
country: Turkey
facility: Ali Turkyilmaz
state: Kirikkale
city: Kırıkkale
country: Turkey
facility: Ali Turkyilmaz
Study officials:
affiliation: Kirikkale University, Faculty of Dentistry
name: Ali Turkyilmaz, PhD
role: STUDY_DIRECTOR
References: