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

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

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Diagnostic test: ENzyme linked immunity-sorbet assays

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• primary teeth with carious pulp exposures during caries removal will be included in the study.
• primary molars with the presence of exudate, purulence or necrotic pulp tissue around the exposure site will be excluded

Description

Inclusion Criteria:

1. healthy children
2. patients had not used any inflammatory medications

3. primary molar teeth of these children were included based on the following clinical and radiographic criteria:

   1. no clinical symptoms or evidence of pulp degeneration (pain on percussion, history of swelling or sinus tract
   2. no spontaneous pain
   3. no radiographic signs of internal or external resorption, widened periodontal ligament space, or furcal/periapical radiolucency
   4. physiological root resorption of no more than one third the root length
   5. a deep caries lesion with a likelihood of pulp exposure during caries removal

Exclusion Criteria:

• patients used any anti-inflammatory medication

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hemostasis achievement; in which hemostasis at the exposure site was achieved in five minutes were included in group A	Diagnostic test: ENzyme linked immunity-sorbet assays; Hemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels
No hemostasis achievement; in which hemostasis at the exposure site couldn't be achieved in five minutes where included in group B	Diagnostic test: ENzyme linked immunity-sorbet assays; Hemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring interleukin 2 (IL-2)	to measure cytokines levels after coronal pulpal removal	After 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)	to measure cytokines levels after coronal pulpal removal	After 5 minutes
Postoperative pain, Bifurcation/periapical radiolucency and Internal/external root resorption Or other pathological changes	To assess postoperative pain by verbal questioning and To observe presence or absence of radiolucency and root resorption or pathological condition	3,6,9,12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: CEBD-CU-2018-10-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No