HemorrhageNCT03737682
Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study.
An observational study of Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of pulp inflammation by hemostasis achievement after pulp exposure Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Hemorrhage
- What is being tested?
- ENzyme linked immunity-sorbet assays
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2019to 14 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- patients used any anti-inflammatory medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Hemorrhage
- Being tested
- ENzyme linked immunity-sorbet assays
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENzyme linked immunity-sorbet assaysDiagnostic test
Hemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels
| Study group | Role | What they receive |
|---|---|---|
| hemostasis achievement | in which hemostasis at the exposure site was achieved in five minutes were included in group A Receives: 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 Receives: Diagnostic Test: ENzyme linked immunity-sorbet assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring interleukin 2 (IL-2)
to measure cytokines levels after coronal pulpal removal
Measured: After 5 minutes
Secondary outcomes (2)
Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)
to measure cytokines levels after coronal pulpal removal
Measured: 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
Measured: 3,6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start30 Jul 2019
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Mohsin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737682
- Sponsor's protocol ID
- CEBD-CU-2018-10-31
- Status last verified
- Aug 2024
- First submitted
- 31 Oct 2018
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study
- ClinicalTrials.gov ID
- NCT03737682
- Acronym / sponsor ID
- CEBD-CU-2018-10-31
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemostasis achievement | – | Diagnostic Test: ENzyme linked immunity-sorbet assaysin which hemostasis at the exposure site was achieved in five minutes were included in group A |
| No hemostasis achievement | – | Diagnostic Test: ENzyme linked immunity-sorbet assaysin which hemostasis at the exposure site couldn't be achieved in five minutes where included in group B |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (1 listed)
- patients used any anti-inflammatory medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENzyme linked immunity-sorbet assaysHemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels | Diagnostic test | No hemostasis achievement, hemostasis achievement |
Primary outcome
Measuring interleukin 2 (IL-2)
Time frame: After 5 minutes
to measure cytokines levels after coronal pulpal removal
2 secondary outcomes
Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)
Time frame: After 5 minutes
Postoperative pain, Bifurcation/periapical radiolucency and Internal/external root resorption Or other pathological changes
Time frame: 3,6,9,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring interleukin 2 (IL-2) (time frame: After 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.