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Completed
NCT07836686
CLINICAL AND RADIOGRAPHIC SUCCESS OF MODIFIED LSTR TECHNIQUES IN PRIMARY SECOND MOLARS
Conditions: Pulp Necrosis, Irreversible Pulpitis
Sex: All
Ages: 4 Years – 11 Years
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Uşak University
Location: Uşak University Faculty of Dentistry Uşak Uşak
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07836686). StuddyBuddy aggregates publicly available trial information.