NCT03327844

Regenerative Endodontic Therapy (RET) for the Management of Immature Non-vital Permanent Teeth in Children

Regenerative Endodontic Therapy (RET) Using Antibiotic Pastes or Calcium Hydroxide Disinfection for the Management of Immature Non-vital Permanent Teeth in Children: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National University Health System, Singapore · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the efficacy of Antibiotic pastes or Calcium hydroxide disinfection on healing of periapical pathology and continued root development of infected non-vital immature permanent teeth in children. In the test group regenerative endodontic therapy (RET) is performed with antibiotics as the disinfecting agent, in the control group RET is performed with Calcium Hydroxide as the disinfecting agent.

Conditions

• Infected Immature Permanent Teeth

Interventions

Type	Name	Description
DRUG	RET using antibiotics (Ciprofloxacin and Metronidazole)	RET using antibiotics Ciprofloxacin and Metronidazole. First Treatment Visit: Local analgesic, tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal drying using paper points. Delivery of mixture of Bi antibiotic paste (Ciprofloxacin and Metronidazole with sterile water). Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstriction, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.
DRUG	RET using non-setting Calcium Hydroxide	First Treatment Visit: Local analgesic, Tooth isolation, access, pulp extirpation and root canal irrigation with 1.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the non-setting Calcium Hydroxide. Tooth access sealed with temporary dressing. Second Treatment Visit: Tooth analgesia using plain local analgesics without vasoconstrictor, isolation and re-access as described above. Irrigation of root canal system using sodium hypochlorite followed by paper point drying. Initiation of bleeding through insertion of a sterile k-file at a length of 2-3 mm beyond the working length into the periapical tissues. Access sealed using resorbable plug, Biodentine, followed by composite resin.

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2017-11-01
• Last updated: 2021-10-21

Locations

2 sites across 1 country: Singapore