This study aims to compare the effectiveness of Lesion Sterilization and Tissue Repair (LSTR) with conventional pulpectomy in treating pulpal lesions in primary molars of pediatric patients aged 4 to 10 years. LSTR is a minimally invasive method that uses antibiotic paste to disinfect infected tissue without full canal instrumentation. Children participating in this study will receive either the LSTR technique or standard pulpectomy, and the clinical and radiographic success of both treatments will be evaluated over a 12-month period. The goal is to determine whether LSTR is a safe and effective alternative to pulpectomy in primary teeth.
This is a prospective, clinical trial conducted at Atatürk University, Department of Pediatric Dentistry. The study compares two endodontic treatment methods for primary molars with pulpal lesions in children aged 4 to 10 years. A total of 108 primary molars will be assigned to two groups: the experimental group receiving Lesion Sterilization and Tissue Repair (LSTR) and the control group receiving conventional pulpectomy. The LSTR group will be treated with a combination of ciprofloxacin and metronidazole antibiotics mixed with iodoform-calcium hydroxide paste, while the pulpectomy group will receive standard chemomechanical canal debridement and obturation with iodoform-calcium hydroxide paste. Each treatment will be followed by restoration using either compomer or stainless steel crown, depending on patient cooperation and clinical setting. Patients will be followed up clinically at 3, 6, and 12 months and radiographically at 6 and 12 months. Treatment success will be evaluated based on the resolution of clinical symptoms and radiographic healing, using the Periapical Index (PAI) and observation of root resorption patterns. The primary objective is to assess whether the LSTR technique achieves similar or superior success rates compared to pulpectomy in terms of both clinical outcomes and radiographic healing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Lesion Sterilization and Tissue Repair (LSTR) is a minimally invasive pulp therapy using ciprofloxacin and metronidazole mixed with iodoform-calcium hydroxide, without canal instrumentation. The access cavity is sealed and restored with SSC or compomer.
Pulpectomy includes mechanical canal preparation, irrigation, and obturation using iodoform-calcium hydroxide paste, followed by final restoration with stainless steel crown or compomer.
Atatürk University Faculty of Dentistry
Erzurum, Yakutiye, Turkey (Türkiye)
Clinical Success Rate of Treated Primary Molars
Clinical success is defined as absence of pain, swelling, sinus tract, and pathological mobility assessed through standardized clinical examination by a pediatric dentist.
Time frame: At 3, 6, and 12 months post-treatment
Radiographic Healing Rate of Treated Primary Molars
Radiographic healing is defined as the resolution of periapical or furcal radiolucency and the absence of pathological root resorption. This will be assessed using the Periapical Index (PAI) scoring system (scale range 1 to 5, where lower scores indicate better healing) by two calibrated evaluators using digital radiographs.
Time frame: At 6 and 12 months post-treatment
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