Biodentine Vital Pulpotomy in Immature Molars

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Pulp Exposure, Dental

Treatments: Procedure: pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04989036

842014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

CALCIUM HYDROXIDE™

Experimental group

Description:

Non-setting Calcium hydroxide Pulpotomy capping agent. Deepak. Promotion Industrial Park, Bari Brahmana, Jammu - 181133 India form : powder and liquid. application : Calcium hydroxide was mixed with saline to a thick consistency immediately before use. The paste was carefully placed on the pulp stump surface 2-3 mm thick over a small sterile wet cotton with a small condenser, and the excess material was scraped off.

Treatment:

Procedure: pulpotomy

Biodentine ™

Experimental group

Description:

Biodentine ™ Pulpotomy capping agent. Calcium Silicate-Based Material.Septodent®, Saint-Maurdes-Fosses, France form: capsule and liquid. application: According to the instructions of manufacture, Biodentine ™powder and liquid were mixed to achieve a creamy consistency, by mixing a single-unit powder part and 5 drops of a single-unit liquid part for 30 seconds by mixing device . Final mixing and adjustment were done manually to obtain the desired consistency for each case

Treatment:

Procedure: pulpotomy