Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID06640231

The Effect of XP-Endo Finisher Activation of Bioceramic Sealer on Postoperative Pain in Mandibular First Molar With Symptomatic Irreversible Pulpitis

Led by Future University in Egypt · Updated on 2025-06-29

30

Participants Needed

1

Research Sites

21 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effect of activating a bio-ceramic root canal sealer with the XP-Endo Finisher on postoperative pain in patients with symptomatic irreversible pulpitis in their mandibular first molars. This condition involves inflammation of the pulp that causes significant pain, and the study aims to examine whether activating the sealer improves sealing and reduces pain compared to using the sealer without activation. The trial is randomized, triple-blinded, and includes adult patients between 18 and 40 years old who require root canal treatment. The study compares two groups of 15 patients each: one group receives root canal treatment using bio-ceramic sealer activated by the XP-Endo Finisher, a specialized rotary instrument designed to enhance sealer penetration and cleaning; the other group receives the bio-ceramic sealer without activation. The XP-Endo Finisher is used after cleaning and shaping the canal to activate the sealer before obturation, aiming to achieve a tight seal and reduce bacterial leakage. The control group’s canals are obturated directly without sealer activation. Participants will be monitored for postoperative pain immediately after obturation and at 6, 12, 24, and 48 hours afterward. Researchers will also track the number of pain relief tablets taken within 48 hours post-treatment. Patients must be systematically healthy and able to understand pain rating scales. The study will help assess whether sealer activation affects pain levels and analgesic use after root canal therapy, with all procedures occurring during the clinical visits spanning the treatment and short-term follow-up period.

CONDITIONS

Brief Title

The Effect of XP-Endo Finisher Activation of Bioceramic Sealer on Postoperative Pain in Mandibular First Molar With Symptomatic Irreversible Pulpitis

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age ranges from 18 to 40 years old.

  • No sex predilection.

  • Patients seeking root canal treatment.

  • Systematically healthy patient (ASA I, II).

  • Patient who can understand numerical rate scale and sign an informed consent.

  • Mandibular first molar teeth with:

  • Preoperative sharp (moderate or severe) pain.

  • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

  • Normal periapical radiographic appearance.

Not Eligible

You will not qualify if you...

  • Patients with American association of anesthesiologists (ASA) classification other than ASA I or II.

  • Patients who have already ingested preoperative medication, such as analgesics, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.

  • Patients with NSAIDs allergy.

  • Patients having two or more adjacent teeth needing root canal therapy.

  • Pregnant patients.

  • Patients with bleeding disorder.

  • Patients with long term corticosteroid use.

  • Teeth having;

  • Necrotic pulp.

  • History or presence of swelling or fistulous tract.

  • Acute or chronic periapical abscess.

  • Mobility more than grade 1.

  • Pocket depth more than 5mm.

  • No possible restorability.

  • Previous root canal treatment.

  • Periapical radiolucency.

  • External or internal resorption.

  • Vertical root fracture.

  • TMJ problems, bruxism, clenching or traumatic occlusion.

  • Inability to understand and perform the given instructions.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment session

Participants receive root canal treatment with either bioceramic sealer activation using XP-Endo Finisher or without sealer activation.

1 visit (in-person)

Follow-up

Duration - 48 hours after treatment

Participants are monitored for postoperative pain and analgesic use after the treatment.

Visits or assessments immediately after treatment and at 6, 12, 24, and 48 hours post-treatment

Trial Site Locations

Total: 1 location

1

Future University in Egypt

Cairo, New Cairo, Egypt, 11835

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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