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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3Mix-MP | Experimental | Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and minocycline (Minoz, 100 mg, Ranbaxy, India) |
|
| Alternative 3Mix-MP | Active Comparator | Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and clindamycin (Klindan, 150 mg capsules, BİLİM, Turkiye) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesion Sterilization and Tissue Repair Therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical success | clinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss. | 12 months |
| radiographic success | radiographic criterion was periapical radiolucency. | 12 months |
| overall success | If at least one of the clinical findings was present, the treatment was considered unsuccessful. However, even if teeth fail radiographically, they are not classified as overall failure if no clinical signs are present. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inonu University, Faculty of dentistry | Malatya | 44000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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This study was a randomized controlled clinical trial that followed the recommendations of the Consolidated Standards of Reporting Trials (CONSORT).
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| Different Antibiotic Combinations | Drug | 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 |
|
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |