New Vital Pulpotomy Medications in Primary Molars

Not Applicable

Active, not recruiting

• Conditions: Carious Exposure of Pulp
• Interventions: Drug: Formocresol; Drug: Biodentine; Drug: Hyaluronic acid gel

• Registration Number: NCT05937100
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-07-07
• Last Update Submitted: 2023-07-07
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control: Formocresol	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 A : (Biodentine)	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 B : (Hyaluronic acid gel)	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.

Primary Outcome Measures

Name	Time	Method
clinically successful pulpotomy	18 months	1. Pain symptom - free teeth on percussion as well as during mastication.; 2. Absence of pathological tooth mobility.; 3. Absence of swelling of pulpal origin.; 4. . Absence of sinus tract.
radiographically successful pulpotomy	18 months	1. No internal or external root resorption.; 2. No periapical or furcation radiolucency.; 3. No widening of periodontal ligament space.

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Mansoura, Egypt