Biodentine Vital Pulpotomy in Immature Molars

NCT04989036 | Completed Phase 4 DMC

• 1 other identifier: 842014
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulp Exposure, Dental

Outcome Measures

Primary Outcomes (2)

• Assessment of pain severity

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

  12 months

• Absences of swelling / fistulous tract

  binary outcome observed clinically

  12 months

Secondary Outcomes (3)

• Absence of tenderness to percussion

  12 months

• Absence of internal or external root resorption

  12 months

• Root maturation

  12 months

Study Arms (2)

CALCIUM HYDROXIDE™

EXPERIMENTAL

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.

Procedure: pulpotomy

Biodentine ™

EXPERIMENTAL

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

Procedure: pulpotomy

Interventions

pulpotomy 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

Also known as: vital pulp therapy, apexogensis

Biodentine ™; CALCIUM HYDROXIDE™

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple blinded (patient, radiographic assessors of results and statistician)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: August 4, 2021
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 year
• Access Criteria: after publication