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Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding

Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding after the extraction of four maxillary primary incisors in children candidates for dental treatment under general anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210419051016N3
Enrollment
30
Registered
2023-06-17
Start date
2023-04-16
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tranexamic Acid, Controlling Bleeding, Gelatamp.

Interventions

Intervention 1: The first intervention group: Gelatamp, after extraction for two teeth, two pieces of Gelatamp (Spongostan, Ferrosan, Denmark) will be placed half inside the socket and after a period

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 4 Years

Inclusion criteria

Inclusion criteria: The need to Extract Primary incisors Age 2 to 4 years Children are not affected to Congenital Hemorrhagic Diseases Children should not receive Anticoagulants The Child does not have a Mental or Physical Disability The Studied Teeth should have less than One-third root Resorption and unmaintainable Crowns Do not take Ibuprofen and Aspirin Painkillers before and after work The Child does not have Contraindications for General Anesthesia The Studied Child only needs to have four Primary incisors Extracted and another Tooth Extracted from the Patient If the Tooth is not Infected and the root has not Decayed to a large extent, it is included in the Study If They do not have Complications during General Anesthesia. (Hypoxia, Blood Pressure drop, Larynx Spasm, etc.)

Exclusion criteria

Exclusion criteria: History of any uncontrolled systemic disease Patients whose parents do not consent to participate in the study for any reason

Design outcomes

Primary

MeasureTime frame
Intensity of Bleeding. Timepoint: The determined time intervals are 10, 5, and 15 minutes after starting to use Gelatamp and gauze impregnated with Tranexamic acid. Method of measurement: Fanning scale.;Bleeding Time. Timepoint: The determined time intervals are 10, 5, and 15 minutes after starting to use Gelatamp and gauze impregnated with Tranexamic acid. Method of measurement: Fanning scale.

Secondary

MeasureTime frame
Oral Health. Timepoint: At the beginning of the study (before the start of the intervention) and Two weeks after the end of the intervention. Method of measurement: Examination of the child's mouth.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Hajiahmadi

Esfahan University of Medical Sciences

dr.maryamhajiahmadi@gmail.com+98 31 3792 5539

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026