Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate

Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate Used As Pulpotomy Agents In Vital Immature Permanent Molars With Irreversible Pulpits. A Randomized Control Trial

The aim of this study is to assess Clinical and Radiographical effect of Bio C repair, Biodentine and Mineral Trioxide Aggregate when used as pulpotomy Agents in Immature Permanent Molars with Pulpits.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Other: Biodentine; Other: Bio C repair

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Children aged 6-10 years with asymptomatic/symptomatic disease and having vital immature permanent posterior teeth with clinical exposure to dental caries of the pulp and bleeding.
2. Posterior teeth had deep caries with pulp exposure.
3. Posterior teeth that exhibited preoperative symptoms, such as referred pain, spontaneous pain or pain induced during thermal and cold sensitivity tests, with a range of symptoms that can last from seconds to hours compared to the control teeth.
4. Posterior teeth without prominent radiolucency in the furcation or periapical regions.
5. The posterior teeth could be restored.
6. Children with prior parental consent.

Exclusion Criteria:

• • (1) Patients with contraindications of the to-be-performed dental treatment.

  • (2) Teeth with completed VPT or RCT.
  • (3) Teeth with furcation, prominent radiolucency in the periapical regions, or external or internal resorption.
  • (4) Teeth with pulpitis attributed to tooth fracture, cracking, periodontitis or wedge-shaped defects.
  • (5) Teeth without any response to experiments of vitality. (
  • 6) Teeth with formed root/closed apex.
  • (7) Teeth with edema, fistula and excessive mobility not associated with periodontal disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodentine; Pulpotomy using Biodentine in carious Immature permanent molars with irreversible pulpitis.	Other: Biodentine; First introduced in 2009 as a "dentin replacement" agent, biodentin is a "bioactive replacement for dentine." It is also available under the trade name Septodont. The material is reported to have better physical and biological properties than other tricalcium silicate cements such mineral trioxide aggregate (MTA) an d BioaggregateTM.
Experimental: Bio C repair; Pulpotomy using Bio C repair in carious Immature permanent molars with irreversible pulpitis.	Other: Bio C repair; A new calcium silicate-based restorative cement called Bio-C Repair (Angelus, Londrina, Brazil) exhibits bioactivity and promotes tissue repair and biomineralisation. This material has a number of benefits, including reduced susceptibility to moisture as compared to traditional substitutes and easy application via a convenient single-use syringe size, which improves clinical efficacy. (Torres et al., 2020). By encouraging bioactivity, biomineralisation, and hard tissue repair, Bio C Repair is used in immature permanent teeth to support apexogenesis (continuous root growth) and pulpotomy. It functions as a biocompatible pulp dressing, promoting tissue regeneration, sealing the pulp chamber, and outperforming conventional techniques with better handling and shorter setting periods.
Active Comparator: MTA; Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis.	Other: Biodentine; First introduced in 2009 as a "dentin replacement" agent, biodentin is a "bioactive replacement for dentine." It is also available under the trade name Septodont. The material is reported to have better physical and biological properties than other tricalcium silicate cements such mineral trioxide aggregate (MTA) an d BioaggregateTM.; Other: Bio C repair; A new calcium silicate-based restorative cement called Bio-C Repair (Angelus, Londrina, Brazil) exhibits bioactivity and promotes tissue repair and biomineralisation. This material has a number of benefits, including reduced susceptibility to moisture as compared to traditional substitutes and easy application via a convenient single-use syringe size, which improves clinical efficacy. (Torres et al., 2020). By encouraging bioactivity, biomineralisation, and hard tissue repair, Bio C Repair is used in immature permanent teeth to support apexogenesis (continuous root growth) and pulpotomy. It functions as a biocompatible pulp dressing, promoting tissue regeneration, sealing the pulp chamber, and outperforming conventional techniques with better handling and shorter setting periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic examination of complete apical closure	Digital Radiographic examination using visual examination of the teeth were made using the TPC paralleling device	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pain	Pain assessment was done by the VAS between 0 and 10, with 0 denoting no pain and 10 denoting severe pain.	12 months
The presence of Swelling	Visual examination	12 months
The presence of Sinus or fistula	Visual examination	12 months
tenderness associated with the tooth.	Wong-Baker FACES Pain Rating Scale (0-10)	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tricalcium silicate
• Other Study ID Numbers: 4-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No