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Biodentine Vital Pulpotomy in Immature Molars

Phase 4
Completed
Conditions
Pulp Exposure, Dental
Registration Number
NCT04989036
Lead Sponsor
Cairo University
Brief Summary

This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™). After a 12 months postoperative period, Biodentine ™ proved very useful as a successful pulpotomy agent in young permanent teeth.

Detailed Description

Objective: This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™).

Participants and methods:

This study was carried out on patients attending an outpatient clinic in Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry - Cairo University - Egypt. A total of thirty-five patients had thirty-eight vital immature first permanent molar with deep caries, who satisfied the eligibility criteria and completed the follow-up period. Their age ranged between six years to nine years old with a mean age of 7.5+/-1 years. All teeth were mandibular. In this study, pulpotomy was performed to preserve the vitality and function of the remaining radicular pulp tissue, followed by applying one of the investigated pulp capping materials.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
Inclusion Criteria
  • Medical history: Healthy children with no physical or mental disorders assured through medical history questioning.
  • Mandibular vital immature first permanent molar with deep caries. Restorable. No clinical evidence of extensive pulp degeneration or periapical pathology.No radiographic evidence of periapical pathosis or interradicular bone loss, internal/external resorption and pulp calcification.
Exclusion Criteria
    1. Patients refuse to cooperate. 2. Spontaneous pain or severe pain which doesn't stop with analgesics. 3. Hemorrhage control wasn't achievable at the operative procedures

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Assessment of pain severity12 months

ordinal outcome measured with direct questioning to the patient using Verbal Rating Scale ( VRS)

Absences of swelling / fistulous tract12 months

binary outcome observed clinically

Secondary Outcome Measures
NameTimeMethod
Root maturation12 months

binary outcome detected in periapical radiograph

Absence of tenderness to percussion12 months

binary outcome detected by back of mirror

Absence of internal or external root resorption12 months

binary outcome detected in periapical radiograph

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