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Completed

NCT Number: NCT07836686

Clinical and Radiographic Success of Modified LSTR Techniques in Primary Second Molars

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.

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Key information

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uşak University Faculty of Dentistry

Uşak, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 4-11 years. Systemically healthy children. Presence of deep caries, pulp necrosis, or irreversible pulpitis in a mandibular primary second molar indicated for LSTR treatment.

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

  • Risk of infective endocarditis. Known allergy to any antibiotic used in the study. Root resorption exceeding one-third of the root length. Extensive furcation involvement extending toward the permanent tooth germ. Insufficient remaining tooth structure for restoration. Parent/legal guardian declining informed consent.

Treatment and study plan

3Mix-MP Antibiotic Paste

Drug

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.

3Mix-NS Antibiotic Paste

Drug

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.

2Mix-MP Antibiotic Paste

Drug

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.

2Mix-NS Antibiotic Paste

Drug

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.

Primary outcomes

  1. Clinical Success of LSTR Treatment

    Time frame: 3, 6, and 12 months after 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

  2. Radiographic Success of LSTR Treatment

    Time frame: 6 and 12 months after 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.

  3. Overall Success of LSTR Treatment

    Time frame: 6 and 12 months after 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.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

EVALUATION OF THE CLINICAL AND RADIOGRAPHIC SUCCESS OF VARIOUS MODIFICATIONS OF THE LESION STERILIZATION AND TISSUE REPAIR TECHNIQUE IN PRIMARY SECOND MOLAR TEETH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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