Clinical trial NCT04989036: Biodentine Vital Pulpotomy in Immature Molars
Official title: Clinical and Radiographic Evaluation of Apexogenesis Using Calcium Hydroxide Pulpotomy Versus Calcium Silicate-Based Material (Biodentine™) Pulpotomy in Cariously Exposed Vital Immature Permanent First Molars: A Randomized Controlled Trial With 12 Months Follow Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulp Exposure, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT), parallel group with 1:1 allocation ratio and equivalence framework. Triple blinded (patient, radiographic assessors of results and statistician) Ethics approval by the Human Research Ethics committee at Faculty of Dentistry- Cairo University was taken.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of pain severity
timeFrame: 12 months
measure: Absences of swelling / fistulous tract
timeFrame: 12 months
Secondary outcomes:
measure: Absence of tenderness to percussion
timeFrame: 12 months
measure: Absence of internal or external root resorption
timeFrame: 12 months
measure: Root maturation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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