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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03737682
• Other study ID #: CEBD-CU-2018-10-31
• Status: Not yet recruiting
• Start date: July 30, 2019
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of pulp inflammation by hemostasis achievement after pulp exposure

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 41
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Diagnostic Test:
• ENzyme linked immunity-sorbet assays
Hemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring interleukin 2 (IL-2)	to measure cytokines levels after coronal pulpal removal	After 5 minutes
Secondary	Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)	to measure cytokines levels after coronal pulpal removal	After 5 minutes
Secondary	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