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

Completed

• Conditions: Hemorrhage
• Interventions: Diagnostic Test: ENzyme linked immunity-sorbet assays

• Registration Number: NCT03737682
• Lead Sponsor: Cairo University

Brief Summary

Assessment of pulp inflammation by hemostasis achievement after pulp exposure

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 Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2019-07-30
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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Exclusion Criteria

• patients used any anti-inflammatory medication

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hemostasis achievement	ENzyme linked immunity-sorbet assays	in which hemostasis at the exposure site was achieved in five minutes were included in group A
No hemostasis achievement	ENzyme linked immunity-sorbet assays	in which hemostasis at the exposure site couldn't be achieved in five minutes where included in group B

Primary Outcome Measures

Name	Time	Method
Measuring interleukin 2 (IL-2)	After 5 minutes	to measure cytokines levels after coronal pulpal removal

Secondary Outcome Measures

Name	Time	Method
Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)	After 5 minutes	to measure cytokines levels after coronal pulpal removal
Postoperative pain, Bifurcation/periapical radiolucency and Internal/external root resorption Or other pathological changes	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

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt