Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biodentine, Bio C repair.
- Who it may be relevant to
- Registry conditions: Pulpitis - Irreversible. Basic parameters: 6 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 u
Primary outcome measures
- Radiographic examination of complete apical closure [Time frame: 12 months]
Secondary outcome measures (4)
- Presence of pain [Time frame: 12 months]
- The presence of Swelling [Time frame: 12 months]
- The presence of Sinus or fistula [Time frame: 12 months]
- tenderness associated with the tooth. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07522723 · 4-2026