Ireland
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Active, not recruiting Phase 2

The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.

NCT06630156 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2
Started
2022-08-21
Last updated
2024-10-15

Condition(s) studied

Revascularization of Immature Young Permenant Teeth

Investigational drug(s) / intervention(s)

Revascularization of Immature Young Permenant Teeth

Revascularization of Immature Young Permenant Teeth: An access cavity was prepared under rubber dam, isolation, root canal system disinfection was done without mechanical instrumentation. Subsequently, triple antibiotic paste was placed into the apical portion of the canal and filled to just below the CEJ. The access cavity was temporarily restored with glass ionomer. 4 weeks later, after reopening of the access, the antibiotic paste was gently flushed out of the canal with sterile normal saline. The root canal system was irrigated. A sterile #35 K-file will be introduced into the canal beyond the apical foramen using a push and pull motion to provoke bleeding from the periapical tissue. After bleeding control and formation of fresh blood clot, 3 mm of Bio (MTA) will be placed in Group A, 3 mm of Total Fill biocearmic root repair material will be placed in Group B after a moist cotton pellet was placed over the capping material and the access cavity will be sealed with G C

Study summary

The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through:

1. Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration.
2. Radiographic evaluation including: Root lengthening, continued thickening of the dentinal walls, apical closure and regression of the peri-apical lesion.

Eligibility

Sex
ALL
Min age
7 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Child with an age ranged from (7-12) year from both sexes. 2. Patient and parent cooperation. 3. Non vital immature permanent teeth indicated for endodontic treatment as a result of pulp necrosis. 4. Patient is not taking antibiotic and has not taken for the past 2 weeks. 5. Restorable teeth. 6. The root to crown ratio should be at least 1:1. Exclusion Criteria: 1. Patients allergic to any drug used in this RCT. 2. Patients with any systemic disease that would contraindicate pulp therapy (rheumatic fever, infective endocarditis, leukemia, corticosteroid therapy and immune suppressed children). 3. Tooth with vital pulp or complete root formation. 4. Teeth with draining sinus or periodontal weak mobile teeth. 5. Teeth with internal or external root resorption. 6. Tooth with root fracture.

Primary outcome measure(s)

  • radiographic parameters — baseline, 3, 6, and 12 months after treatment
    continued root lengthening and thickening of the dentinal walls in mm

Trial sites (1)

FacilityCityRegionStatus
faculty of dental medicine, Al-Azhar university Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06630156 on ClinicalTrials.gov ↗ ← All trials in Egypt