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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorCairo University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

• (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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biodentine

    Other intervention

    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.

  • Bio C repair

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: BiodentineExperimental treatment 1 intervention
Group B: Bio C repairExperimental treatment 1 intervention
Group C: MTAActive comparator 2 interventions

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

Presence of pain

Pain assessment was done by the VAS between 0 and 10, with 0 denoting no pain and 10 denoting severe pain.

Time frame
12 months
2

The presence of Swelling

Visual examination

Time frame
12 months
3

The presence of Sinus or fistula

Visual examination

Time frame
12 months
4

tenderness associated with the tooth.

Wong-Baker FACES Pain Rating Scale (0-10)

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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