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

N/ANot Yet RecruitingNCT07522723

Cairo University60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulpitis - Irreversible

Interventions

BiodentineOTHER

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 repairOTHER

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

The presence of Swelling

Visual examination

Time frame: 12 months

The presence of Sinus or fistula

Visual examination

Time frame: 12 months

tenderness associated with the tooth.

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

Time frame: 12 months

Data from ClinicalTrials.gov

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