NCT06818578

Success of Lesion Sterilization and Tissue Repair Therapy

Evaluation of the Clinical and Radiographic Success of Different Antibiotic Combinations in Lesion Sterilization and Tissue Repair Therapy for Infected Primary Molar Teeth

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Inonu University · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Accepted

Summary

This study aimed to assess the clinical and radiographic success of lesion sterilization and tissue repair (LSTR) therapy with different antibiotic combinations, focusing on evaluating whether the alternative combination of clindamycin instead of minocycline is as effective as the standard 3Mix-MP formulation.

Detailed description

All the clinical procedures were carried out by one clinician with 2 years of clinical experience in pediatric dentistry under rubber dam isolation and local anesthesia via mandibular nerve block. (Maxicaine Fort Ampoule, VEM, Turkiye). After the removal of carious tissues, an endodontic cavity was prepared, and infected coronal pulp tissue was removed up to the canal orifices via a sterile round steel bur. A sterile round steel bur was then used to prepare a medication cavity 2 mm deep and 1 mm wide. The root canals were not instrumented, and only the access cavity was irrigated with a 2.5% NaOCl solution. In cases where hemostasis could not be achieved, a sterile cotton pellet soaked in 5% NaOCl was placed in the pulp chamber and left for 1 minute. Once hemostasis was achieved, the endodontic cavity was dried using a sterile, dry cotton pellet. Pastes were then applied to the medication cavity and covered with a glass ionomer cement (Nova Glass II F, Imicryl, Turkiye) and a stainless steel crown (Kids Crown, Shinhung, Seoul, Korea) at the same visit. Clinical and radiographic evaluations were performed at 1, 3, 6, 9, and 12 months. During follow-up, the teeth were assessed on the basis of the following clinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss. The radiographic criterion was periapical radiolucency.

Conditions

• Primary Teeth
• Pulp Necrosis
• Pulpitis - Irreversible

Interventions

Type	Name	Description
PROCEDURE	Lesion Sterilization and Tissue Repair Therapy	LSTR treatment is a minimally invasive, cost-effective, and easy-to-apply procedure for necrotic primary teeth, with a focus on disinfection with an antibiotic mixture without the need for root canal instrumentation.
DRUG	Different Antibiotic Combinations	Clinical and Radiographic Success of Different Antibiotic Combinations (evaluating whether the alternative 3Mix-MP combination of clindamycin instead of minocycline is as effective as the standard 3Mix-MP formulation) in Lesion Sterilization and Tissue Repair Therapy

Timeline

• Start date: 2022-09-14
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2025-02-10
• Last updated: 2025-02-11

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study