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

NCT07522723 | Not Yet Recruiting

• 1 other identifier: 4-2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Presence of pain

  12 months

• The presence of Swelling

  12 months

• The presence of Sinus or fistula

  12 months

• tenderness associated with the tooth.

  12 months

Study Arms (3)

Biodentine

EXPERIMENTAL

Pulpotomy using Biodentine in carious Immature permanent molars with irreversible pulpitis.

Other: Biodentine

Bio C repair

EXPERIMENTAL

Pulpotomy using Bio C repair in carious Immature permanent molars with irreversible pulpitis.

Other: Bio C repair

MTA

ACTIVE COMPARATOR

Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis.

Other: Biodentine; Other: Bio C repair

Interventions

Biodentine OTHER

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.

Biodentine; MTA

Bio C repair OTHER

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.

Bio C repair; MTA

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Posterior teeth had deep caries with pulp exposure.
• 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.
• Posterior teeth without prominent radiolucency in the furcation or periapical regions.
• The posterior teeth could be restored.
• Children with prior parental consent.

You may not qualify if:

• (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. (
• \) Teeth with formed root/closed apex.
• (7) Teeth with edema, fistula and excessive mobility not associated with periodontal disease.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

tricalcium silicate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04