Comparison of LSTR and Pulpectomy in Primary Molars of Pediatric Patients (LSTR-PULP)

taymour abuawwad

Status: Active, not recruiting

Conditions: Dental Caries; Pediatric Dentistry; Periapical Periodontitis; Primary Tooth Pulpectomy; Pulpal Necrosis

Treatments: Procedure: LSTR; Procedure: Pulpectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07026435

TDK-2024-14564 (Other Identifier)

B.30.2.ATA.0.01.00/477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

LSTR Group

Experimental group

Description:

Children will receive the LSTR (Lesion Sterilization and Tissue Repair) procedure, which includes applying a mixture of ciprofloxacin and metronidazole with iodoform-calcium hydroxide paste to the pulp chamber without canal instrumentation. Restoration will be done using a stainless steel crown or compomer.

Treatment:

Procedure: LSTR

Pulpectomy Group

Active Comparator group

Description:

Children will receive conventional pulpectomy involving mechanical canal instrumentation and obturation with iodoform-calcium hydroxide paste. Restoration will be completed with a stainless steel crown or compomer based on clinical conditions.

Treatment:

Procedure: Pulpectomy