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Completed

NCT Number: NCT05956613

Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis

The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question[s] it aims to answer are:

• In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?

Participants will record the intensity of pain at 24,48, 72 hours postoperatively.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Pulpitis Stomatognathic Diseases Tooth Diseases

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Dentistry, October 6 University

Giza, 12573, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

  • Inclusion criteria :
  • Subject's age between 9-14 years.
  • Both male and female subjects.
  • Medically free and healthy subjects.
  • Mandibular molar teeth.
  • Teeth with symptomatic irreversible pulpitis.
  • Teeth with mature closed apices.
  • Exclusion Criteria:
  • Teeth with acute dentoalveolar abscess.
  • Subjects having more than one tooth that require root canal treatment.
  • Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
  • Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
  • Teeth with periodontal disease or pulp calcification.
  • Subjects taking chronic pain medications.

Treatment and study plan

Partial pulpotomy

Procedure

Use of newly introduced bioceramic putty in partial pulpotomy

Primary outcomes

  1. Post operative pain

    Time frame: after 24 hours

    Measure intensity of post operative pain using visual analogue scale (VAS)

  2. Post operative pain

    Time frame: after 48 hours

    Measure intensity of post operative pain using visual analogue scale (VAS)

  3. Post operative pain

    Time frame: After 72 hours

    Measure intensity of post operative pain using visual analogue scale (VAS)

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

Evaluation of Postoperative Pain After Partial Pulpotomy Versus Full Root Canal Treatment in Managing Young Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
May 14, 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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