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Completed

NCT Number: NCT03737682

Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study.

Assessment of pulp inflammation by hemostasis achievement after pulp exposure

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo university

Cairo, Egypt

About this study

The possibility has been raised of diagnosing pulpal pathological status using the cytokines that are released during the inflammation process in healthy as well as infected tooth pulp. Cytokines are small polypeptides secreted by leucocytes and other inflammatory cells and are known to play important roles in the intensity and duration of the immune response

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • healthy children
  • patients had not used any inflammatory medications
  • primary molar teeth of these children were included based on the following clinical and radiographic criteria:
  • no clinical symptoms or evidence of pulp degeneration (pain on percussion, history of swelling or sinus tract
  • no spontaneous pain
  • no radiographic signs of internal or external resorption, widened periodontal ligament space, or furcal/periapical radiolucency
  • physiological root resorption of no more than one third the root length
  • a deep caries lesion with a likelihood of pulp exposure during caries removal

Exclusion criteria

  • patients used any anti-inflammatory medication

Treatment and study plan

ENzyme linked immunity-sorbet assays

Diagnostic Test

Hemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels

Primary outcomes

  1. Measuring interleukin 2 (IL-2)

    Time frame: After 5 minutes

    to measure cytokines levels after coronal pulpal removal

Secondary outcomes

  1. Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)

    Time frame: After 5 minutes

    to measure cytokines levels after coronal pulpal removal

  2. Postoperative pain, Bifurcation/periapical radiolucency and Internal/external root resorption Or other pathological changes

    Time frame: 3,6,9,12 months

    To assess postoperative pain by verbal questioning and To observe presence or absence of radiolucency and root resorption or pathological condition

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2018
Registry last updated
Aug 15, 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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