New Vital Pulpotomy Medications in Primary Molars

Carious Exposure of Pulp Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05937100
• Other study ID #: A0103023PP
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Carious Exposure of Pulp

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Dentistry	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically successful pulpotomy	Pain symptom - free teeth on percussion as well as during mastication.; Absence of pathological tooth mobility.; Absence of swelling of pulpal origin.; . Absence of sinus tract.	18 months
Primary	radiographically successful pulpotomy	No internal or external root resorption.; No periapical or furcation radiolucency.; No widening of periodontal ligament space.	18 months