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New Vital Pulpotomy Medications in Primary Molars

NCT05937100 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-30

No results posted yet for this study

Summary

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

Conditions

  • Carious Exposure of Pulp

Interventions

DRUG

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

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Weaam I El-tantawy · assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016)

  • Nadia M Farrag · Professor ,Faculty of Dentistry, Mansoura University

  • Hossam E Hammouda · Lecturer, Faculty of Dentistry, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-07-01
Completion
2025-08-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937100 on ClinicalTrials.gov