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Clinical Trials in Egypt / NCT05937100
Active, not recruiting Not applicable

New Vital Pulpotomy Medications in Primary Molars

NCT05937100 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2023-05-01
Last updated
2025-05-30

Condition(s) studied

Carious Exposure of Pulp

Investigational drug(s) / intervention(s)

Formocresol →Biodentine →Hyaluronic acid gel →

Formocresol: Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute

Biodentine: Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps

Hyaluronic acid gel: Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes.

Study summary

Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.

Eligibility

Sex
ALL
Min age
4 Years
Max age
7 Years
Healthy volunteers
Accepted
Inclusion Criteria: * -Clinical criteria 1. Restorable mandibular primary molars with deep carious lesions. 2. Absence of gingival swelling or sinus tract. 3. Absence of spontaneous pain 4. Absence of pain on percussion. B-Radiographic Criteria: Absence of <!-- --> 1. Discontinuity of lamina dura 2. Internal root resorption. 3. External root resorption. 4. inter-radicular or periapical bone destruction (radiolucency) Exclusion Criteria: 1. Excessive bleeding during pulp amputation. 2. Non vital/necrotic teeth. 3. Any sort of medical history contraindicating the pulp treatment. 4. Teeth approximate exfoliation 5. Patient's guardians are not intending to be part of the study. 6. Retreatment of previously pulpotomy treated molar -

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dentistry Al Mansurah Egypt

More Mansoura University trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05937100 on ClinicalTrials.gov ↗ ← All trials in Egypt