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

Comparison of Lesion Sterilization and Tissue Repair Technique With Conventional Pulpectomy in the Treatment of Pulpal Lesions in Primary Molars in Children

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Periapical Periodontitis; Pediatric Dentistry; Pulpal Necrosis; Primary Tooth Pulpectomy
• Intervention / Treatment: Procedure: LSTR; Procedure: Pulpectomy

Detailed Description

This is a prospective, comparative clinical trial conducted at Atatürk University, Department of Pediatric Dentistry, Erzurum, Turkey. The study compares two endodontic treatment methods for primary molars with pulpal lesions in children aged 4 to 10 years. A total of 110 primary molar teeth from 98 pediatric patients were included. Teeth were assigned to two main treatment groups: the experimental group receiving Lesion Sterilization and Tissue Repair (LSTR) and the control group receiving conventional pulpectomy. Each group was further divided into two subgroups based on the type of final restoration - stainless steel crown (SSC) or compomer - resulting in four treatment-restoration combinations: LSTR + SSC, LSTR + compomer, pulpectomy + SSC, and pulpectomy + compomer. Restoration type was determined based on patient cooperation and parental preference.

The LSTR group was treated with a combination of ciprofloxacin and metronidazole antibiotics mixed with iodoform-calcium hydroxide paste (Viopex), applied to the canal orifices without mechanical instrumentation. The pulpectomy group received standard chemomechanical canal debridement and obturation with iodoform-calcium hydroxide paste. Both groups were subsequently restored with either SSC or compomer.

Patients were followed up clinically and radiographically at 3, 6, and 12 months. Clinical parameters assessed included spontaneous pain, percussion sensitivity, abscess, fistula, and pathological mobility. Radiographic parameters included periapical and interradicular lesion resolution, internal root resorption, and external root resorption. Overall tooth survival was evaluated using Kaplan-Meier survival analysis and Log-Rank test. The primary objective was to assess whether LSTR achieves similar clinical and radiographic success compared to conventional pulpectomy, and to determine the effect of restoration type on long-term treatment outcomes.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yakutiye
    • Erzurum, Yakutiye, Turkey (Türkiye), 25240
      • Atatürk University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LSTR Group; 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.	Procedure: LSTR; 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.
Active Comparator: Pulpectomy Group; 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.	Procedure: Pulpectomy; Pulpectomy includes mechanical canal preparation, irrigation, and obturation using iodoform-calcium hydroxide paste, followed by final restoration with stainless steel crown or compomer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3, 6, and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Healing Rate of Treated Primary Molars	Radiographic healing is defined as the resolution of periapical or interradicular radiolucency, and the absence of pathological root resorption progression. Radiographic assessment was performed by evaluating the presence or absence of periapical/interradicular lesions, internal root resorption, and external root resorption on digital periapical radiographs. Note: The Periapical Index (PAI) scoring system was originally planned but was not applied due to the radiographic characteristics of primary teeth and the nature of the lesions encountered; descriptive radiographic assessment was used instead."	At 6 and 12 months post-treatment

Collaborators and Investigators

• Sponsor: taymour abuawwad
• Investigators: Principal Investigator: Sera DERELİOĞLU, DDS, PhD, Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Actual): September 14, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: May 19, 2025
• First Submitted That Met QC Criteria: June 10, 2025
• First Posted (Actual): June 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pulpectomy; Primary teeth; LSTR; Triple antibiotic paste
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Necrosis; Tooth Demineralization; Periodontitis; Pathological Conditions, Signs and Symptoms; Periapical Periodontitis; Dental Pulp Necrosis; Dental Caries; Dentistry; Endodontics; Pulpectomy
• Other Study ID Numbers: B.30.2.ATA.0.01.00/477; TDK-2024-14564 (Other Identifier: Ataturk University Scientific Research Projects Unit (BAP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No