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Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques

Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06075550
Enrollment
60
Registered
2023-10-10
Start date
2021-06-02
Completion date
2022-03-20
Last updated
2023-10-10

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

Conditions

Effect of Material and Technique

Brief summary

60 patients were divided into 2 groups, 30 patient in each group Group I: Obturation with TotalFill BC Sealer using the single cone technique Group II: Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique. Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.

Detailed description

Endodontic treatment will be performed in a single visit Root canal preparation * After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab. * All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant. * Cleaning and shaping of the canal will be performed using rotary ProTaper Next files (Dentsply, Maillefer) connected to an endodontic motor according to the manufacturer's instructions and recommendations. * Irrigation with sodium hypochlorite will be always performed during instrumentation. * After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points. * Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups. Root canal obturation * This study will be a double blind randomized study. * Group I: Using TotalFill BC Sealer, the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer. A ProTaper Next gutta percha cone (Dentsply, Maillefer) of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser. * Group II: TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done. The depth of the heated plugger will be 5 mm less than the WL followed by back filling. * After obturation, the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling. * A postoperative radiograph will be taken Assessment of postoperative pain Every participant will be given a Visual Analog Scale (VAS) to record the intensity of postoperative pain at 6 hr, 24 hr, 48 hr, 72 hr, and 1week after treatment. The patients will return their Visual Analog Scale (VAS) after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group.

Interventions

OTHERsingle cone technique using TotalFill BC Sealer

Gutta percha cone size X5 (Dentsply, Maillefer) TotalFill BC Sealer (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)

OTHERwarm vertical compaction technique using TotalFill BC Sealer HiFlow

TotalFill BC Sealer HiFlow (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Medically free patients * Patients age between 20-50 years * Vital pulp as indicated by thermal or electric pulp test * No history of previously initiated root canal treatment among the treated tooth * Sufficient tooth structure for isolation * Teeth with mature apices

Exclusion criteria

* Pregnancy or lactation * Medically compromised patients * Previous endodontic therapy of the tooth to be treated. * Teeth diagnosed with non-vital pulp. * Periodontally compromised teeth (teeth with periodontal probing depth more than 3mm). * Teeth with abnormal anatomy or calcified canals. * Teeth with caries below the bony level (non-restorable tooth). * Immature teeth with open apices. * Complications during treatment (file separation, ledges, perforation, etc.) * Overfilling (overextended beyond the radiographic apex) or short filling (more than 2mm of the radiographic apex) * Radiographic evidence of root resorption * Patients who could not follow the instructions to record the visual analog scale

Design outcomes

Primary

MeasureTime frameDescription
change of postoperative pain (Visual Analog Scale )postoperative pain at 6 hoursnumerical (0-10)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026