New Vital Pulpotomy Medications in Primary Molars

NCT ID: NCT05937100

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-08-01

Brief Summary

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

Detailed Description

Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:

1. Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

2. Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

Conditions

Carious Exposure of Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control: Formocresol

Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.

Group Type: ACTIVE_COMPARATOR

Formocresol

Intervention Type: DRUG

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

Group A : (Biodentine)

The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set.

Group Type: EXPERIMENTAL

Biodentine

Intervention Type: DRUG

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

Group B : (Hyaluronic acid gel)

Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.

Group Type: EXPERIMENTAL

Hyaluronic acid gel

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

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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 -

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Weaam ibrahiem eltantawy

assistant lecturer at pediatric department-Mansoura University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weaam I El-tantawy

Role: PRINCIPAL_INVESTIGATOR

assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016)

Nadia M Farrag

Role: STUDY_DIRECTOR

Professor ,Faculty of Dentistry, Mansoura University

Hossam E Hammouda

Role: STUDY_DIRECTOR

Lecturer, Faculty of Dentistry, Mansoura University

Locations

Dentistry

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

A0103023PP

Identifier Type: -

Identifier Source: org_study_id