An interventional study of 3Mix-MP Antibiotic Paste and 3Mix-NS Antibiotic Paste in Pulp Necrosis and Irreversible Pulpitis, sponsored by Uşak University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Uşak University · Not applicable, Interventional, and Treatment
This study aimed to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars. The study included systemically healthy children aged 4-11 years. Participants were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and vehicle used [Macrogol-Propylene Glycol (MP) or normal saline (NS)]: 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS. Clinical outcomes were evaluated at 3, 6, and 12 months after treatment, and radiographic outcomes were evaluated at 6 and 12 months. The clinical and radiographic success of the four LSTR modifications was compared over the 12-month follow-up period.
This study was conducted to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars.
A total of 64 systemically healthy children aged 4-11 years were included in the study. The cases were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and the vehicle used [Macrogol-Propylene Glycol (MP) or Normal saline (NS)]. The four treatment groups were 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS.
Following LSTR treatment, clinical evaluations were performed at 3, 6, and 12 months, while radiographic evaluations were performed at 6 and 12 months. Clinical and radiographic findings were assessed at the specified follow-up periods to determine treatment success and to compare the outcomes of the four LSTR modifications over a 12-month follow-up period.
Patients unsuitable for conventional pulpectomy due to poor cooperation. At least 6 months remaining before physiological exfoliation of the affected tooth.
Root resorption not exceeding one-third of the root length. No furcation perforation. Furcation radiolucency not extending to the permanent tooth germ. Sufficient remaining tooth structure for restoration. Parent/legal guardian willing to provide informed consent.
Exclusion Criteria:
Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.
Drug: 3Mix-MP Antibiotic Paste
Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with normal saline (NS) as the vehicle.
Drug: 3Mix-NS Antibiotic Paste
Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.
Drug: 2Mix-MP Antibiotic Paste
Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with normal saline (NS) as the vehicle.
Drug: 2Mix-NS Antibiotic Paste
The 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
The 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
The 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
The 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.
Clinical Success of LSTR Treatment
Clinical success was defined as the absence of pain or tenderness, swelling or fistula, pathological mobility, and tenderness to percussion. The presence of any of these signs or symptoms was considered clinical failure
Time frame: 3, 6, and 12 months after treatment
Radiographic Success of LSTR Treatment
Radiographic success was defined as stabilization, reduction, or complete resolution of existing interradicular and periradicular radiolucency, with no development of new radiographic lesions. Failure to meet any of these criteria was considered radiographic failure.
Time frame: 6 and 12 months after treatment
Overall Success of LSTR Treatment
Overall treatment success was defined as fulfillment of both the clinical and radiographic success criteria. A case was considered unsuccessful if either the clinical or radiographic success criteria were not met.
Time frame: 6 and 12 months after treatment
Plan to share: No
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Uşak University