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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07522723
Enrollment
60
Registered
2026-04-13
Start date
2026-04-20
Completion date
2027-05-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

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.

Interventions

OTHERBiodentine

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.

OTHERBio 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic examination of complete apical closure12 monthsDigital Radiographic examination using visual examination of the teeth were made using the TPC paralleling device

Secondary

MeasureTime frameDescription
Presence of pain12 monthsPain assessment was done by the VAS between 0 and 10, with 0 denoting no pain and 10 denoting severe pain.
The presence of Swelling12 monthsVisual examination
The presence of Sinus or fistula12 monthsVisual examination
tenderness associated with the tooth.12 monthsWong-Baker FACES Pain Rating Scale (0-10)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026