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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 60
- Primary Endpoint
- Radiographic examination of complete apical closure
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Biodentine
Pulpotomy using Biodentine in carious Immature permanent molars with irreversible pulpitis.
Intervention: Biodentine (Other)
MTA
Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis.
Intervention: Biodentine (Other)
Bio C repair
Pulpotomy using Bio C repair in carious Immature permanent molars with irreversible pulpitis.
Intervention: Bio C repair (Other)
MTA
Mineral trioxide aggregate in carious Immature permanent molars with irreversible pulpitis.
Intervention: Bio C repair (Other)
Outcomes
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
- The presence of Sinus or fistula(12 months)
- tenderness associated with the tooth.(12 months)
- Presence of pain(12 months)
- The presence of Swelling(12 months)
Investigators
Alaa Yasser ElSheikh
PhD candidate
Cairo University