Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07018284

Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers

Led by University of Siena · Updated on 2025-06-12

270

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Siena

Lead Sponsor

U

Universidad Rey Juan Carlos

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the incidence and intensity of pain after root canal treatments in patients with teeth diagnosed with pulpitis, pulp necrosis, or prior endodontic treatment. This study aims to find out if the type of sealer used during root canal obturation, either bioceramic or resin-based, affects the level of postoperative pain reported by patients. Pain will be measured using the Visual Analogue Scale at three time points: right after treatment, 24 hours later, and 72 hours after treatment. The study involves four treatment groups where root canals will be filled using different combinations of sealers and techniques. One group uses AH Plus resin-based sealer with continuous wave condensation using thermoplasticized gutta-percha. Another uses AH Plus with the single cone technique and cold gutta-percha. The other two groups use NeoSealer Flo bioceramic sealer with either continuous wave condensation or the single cone technique. These methods represent different approaches to obturating the root canal. Participants will be monitored for postoperative pain intensity at specified intervals and assessed for radiographic success using the Periapical Index criteria at least six months after treatment. Clinical success will also be evaluated by checking for absence of symptoms and using CBCT imaging. The total participation timeline includes follow-up assessments six months or more after the initial root canal therapy to observe healing and treatment outcomes.

CONDITIONS

Brief Title

Postoperative Pain Evaluation After Obturation With Different Sealers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years and older
  • Teeth diagnosed with pulpal necrosis or irreversible pulpitis
  • Informed consent provided for data usage
Not Eligible

You will not qualify if you...

  • Patients with systemic conditions that may impair healing, such as uncontrolled diabetes or immunosuppression
  • Asymptomatic presentation
  • Teeth with root fractures, resorption, or open apices
  • Incomplete clinical or radiographic records
  • Poor-quality radiographs or lack of standardization for evaluation purposes only

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive root canal obturation using either a resin-based or bioceramic sealer combined with different obturation techniques.

1 treatment visit (in-person)

Follow-up

Duration - At least 6 months

Participants are monitored for postoperative pain and treatment success through clinical and radiographic evaluations.

Follow-up visits for radiographic and clinical assessments over 6 months

Trial Site Locations

Total: 1 location

1

Universidad Rey Juan Carlos , Madrid, Spain 28922

Madrid, Spain, 28922

Actively Recruiting

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Research Team

G

Giulia Malvicini, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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