Clinical trial NCT07026435: Comparison of LSTR and Pulpectomy in Primary Molars of Pediatric Patients (LSTR-PULP)
Official title: Comparison of Lesion Sterilization and Tissue Repair Technique With Conventional Pulpectomy in the Treatment of Pulpal Lesions in Primary Molars in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulpal Necrosis
Dental Caries
Periapical Periodontitis
Pediatric Dentistry
Primary Tooth Pulpectomy
Keywords: LSTR
Pulpectomy
Primary teeth
Triple antibiotic paste
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children aged 4 to 10 years.
* Presence of at least one primary molar with pulpal involvement requiring endodontic treatment.
* Good general health without systemic conditions.
* Signed informed consent from parent or legal guardian.

Exclusion Criteria:

* Children with systemic diseases or immune-compromising conditions.
* Known allergies to any of the materials or antibiotics used in the study.
* Uncooperative behavior preventing dental treatment under normal clinical conditions.
* Teeth with non-restorable crown structure or excessive root resorption.

Primary outcomes:
measure: Clinical Success Rate of Treated Primary Molars
timeFrame: At 3, 6, and 12 months post-treatment
Secondary outcomes:
measure: Radiographic Healing Rate of Treated Primary Molars
timeFrame: At 6 and 12 months post-treatment
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University Faculty of Dentistry
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Sera DERELİOĞLU, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: