New Vital Pulpotomy Medications in Primary Molars

Mansoura University

Status: Active, not recruiting

Conditions: Carious Exposure of Pulp

Treatments: Drug: Hyaluronic acid gel; Drug: Biodentine; Drug: Formocresol

Study type: Interventional

Funder types: Other

Identifiers

NCT05937100

A0103023PP

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups

control: Formocresol

Active Comparator group

Description:

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.

Treatment:

Drug: Formocresol

Group A : (Biodentine)

Experimental group

Description:

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.

Treatment:

Drug: Biodentine

Group B : (Hyaluronic acid gel)

Experimental group

Description:

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.

Treatment:

Drug: Hyaluronic acid gel