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

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

Radiographic examination of complete apical closure

Time frame: 12 months

Digital Radiographic examination using visual examination of the teeth were made using the TPC paralleling device

Secondary outcomes

Presence of pain

Time frame: 12 months

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

Time frame: 12 months

Visual examination
The presence of Sinus or fistula

Time frame: 12 months

Visual examination
tenderness associated with the tooth.

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 13, 2026
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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