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NCT Number: NCT07026435

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

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.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LSTR

Procedure

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

Procedure

Pulpectomy includes mechanical canal preparation, irrigation, and obturation using iodoform-calcium hydroxide paste, followed by final restoration with stainless steel crown or compomer.

Primary outcomes

  1. Clinical Success Rate of Treated Primary Molars

    Time frame: At 3, 6, and 12 months post-treatment

    Clinical success is defined as absence of pain, swelling, sinus tract, and pathological mobility assessed through standardized clinical examination by a pediatric dentist.

Secondary outcomes

  1. Radiographic Healing Rate of Treated Primary Molars

    Time frame: At 6 and 12 months post-treatment

    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."

Sponsors and collaborators

Lead sponsor

taymour abuawwad

Other

Registry information

Official study title

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

Acronym: LSTR-PULP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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