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

NCT07026435 | Active Not Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/477TDK-2024-14564
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

LSTR; Pulpectomy; Primary teeth; Triple antibiotic paste

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographic Healing Rate of Treated Primary Molars

  At 6 and 12 months post-treatment

Study Arms (2)

LSTR Group

EXPERIMENTAL

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

Pulpectomy Group

ACTIVE COMPARATOR

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

Interventions

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.

LSTR Group

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.

Pulpectomy Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• taymour abuawwad: lead

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Dental Caries; Periapical Periodontitis

Interventions

Pulpectomy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tooth Demineralization; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Sera DERELİOĞLU, DDS, PhD

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate in Pediatric Dentistry

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 18, 2025
• Study Start: August 16, 2024
• Primary Completion: April 8, 2025
• Study Completion: October 8, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)