Biodentine Vital Pulpotomy in Immature Molars

NCT ID: NCT04989036

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-11-01

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.

Conditions

Pulp Exposure, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CALCIUM HYDROXIDE™

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.

Group Type: EXPERIMENTAL

pulpotomy

Intervention Type: PROCEDURE

Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed

Biodentine ™

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

Group Type: EXPERIMENTAL

pulpotomy

Intervention Type: PROCEDURE

Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed

Interventions

pulpotomy

Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed

Intervention Type: PROCEDURE

Other Intervention Names

vital pulp therapy; apexogensis

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shereen H Elshamy

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

842014

Identifier Type: -

Identifier Source: org_study_id