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

NCT03737682 | Completed DMC

• 1 other identifier: CEBD-CU-2018-10-31
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of pulp inflammation by hemostasis achievement after pulp exposure

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Measuring interleukin 2 (IL-2)

  to measure cytokines levels after coronal pulpal removal

  After 5 minutes

Secondary Outcomes (2)

• Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)

  After 5 minutes

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

  3,6,9,12 months

Study Arms (2)

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

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

Interventions

ENzyme linked immunity-sorbet assays DIAGNOSTIC_TEST

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

No hemostasis achievement; hemostasis achievement

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• patients used any anti-inflammatory medication

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 9, 2018
• Study Start: July 30, 2019
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

EG (1)