CLINICAL AND RADIOGRAPHIC SUCCESS OF MODIFIED LSTR TECHNIQUES IN PRIMARY SECOND MOLARS

NCT07836686 | Completed

• 1 other identifier: 492-492-10
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars. The study included systemically healthy children aged 4-11 years. Participants were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and vehicle used \[Macrogol-Propylene Glycol (MP) or normal saline (NS)\]: 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS. Clinical outcomes were evaluated at 3, 6, and 12 months after treatment, and radiographic outcomes were evaluated at 6 and 12 months. The clinical and radiographic success of the four LSTR modifications was compared over the 12-month follow-up period.

Conditions

Pulp Necrosis; Irreversible Pulpitis

Keywords

Double Antibiotic Paste; LSTR; Primary Molar Teeth; Triple Antibiotic Paste

Outcome Measures

Primary Outcomes (3)

• Clinical Success of LSTR Treatment

  Clinical success was defined as the absence of pain or tenderness, swelling or fistula, pathological mobility, and tenderness to percussion. The presence of any of these signs or symptoms was considered clinical failure

  3, 6, and 12 months after treatment

• Radiographic Success of LSTR Treatment

  Radiographic success was defined as stabilization, reduction, or complete resolution of existing interradicular and periradicular radiolucency, with no development of new radiographic lesions. Failure to meet any of these criteria was considered radiographic failure.

  6 and 12 months after treatment

• Overall Success of LSTR Treatment

  Overall treatment success was defined as fulfillment of both the clinical and radiographic success criteria. A case was considered unsuccessful if either the clinical or radiographic success criteria were not met.

  6 and 12 months after treatment

Study Arms (4)

3Mix-MP

EXPERIMENTAL

Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.

Drug: 3Mix-MP Antibiotic Paste

3Mix-NS

EXPERIMENTAL

Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with normal saline (NS) as the vehicle.

Drug: 3Mix-NS Antibiotic Paste

2Mix-MP

EXPERIMENTAL

Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.

Drug: 2Mix-MP Antibiotic Paste

2Mix-NS

EXPERIMENTAL

Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with normal saline (NS) as the vehicle.

Drug: 2Mix-NS Antibiotic Paste

Interventions

3Mix-MP Antibiotic Paste DRUG

The 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.

3Mix-MP

2Mix-MP Antibiotic Paste DRUG

The 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Macrogol and propylene glycol were mixed in a 1:1 ratio to prepare the vehicle. Immediately before application, the antibiotic powder and the vehicle were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.

2Mix-MP

2Mix-NS Antibiotic Paste DRUG

The 2Mix antibiotic powder consisted of metronidazole and ciprofloxacin mixed in a 1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.

2Mix-NS

3Mix-NS Antibiotic Paste DRUG

The 3Mix antibiotic powder consisted of metronidazole, ciprofloxacin, and clindamycin mixed in a 1:1:1 ratio. Normal saline (NS) was used as the vehicle. Immediately before application, the antibiotic powder and normal saline were combined at a 7:1 ratio to form a homogeneous paste, which was used as part of the LSTR treatment.

3Mix-NS

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-11 years.
• Systemically healthy children.
• Presence of deep caries, pulp necrosis, or irreversible pulpitis in a mandibular primary second molar indicated for LSTR treatment.
• Patients unsuitable for conventional pulpectomy due to poor cooperation.
• At least 6 months remaining before physiological exfoliation of the affected tooth.
• Root resorption not exceeding one-third of the root length.
• No furcation perforation.
• Furcation radiolucency not extending to the permanent tooth germ.
• Sufficient remaining tooth structure for restoration.
• Parent/legal guardian willing to provide informed consent.

You may not qualify if:

• Risk of infective endocarditis.
• Known allergy to any antibiotic used in the study.
• Root resorption exceeding one-third of the root length.
• Extensive furcation involvement extending toward the permanent tooth germ.
• Insufficient remaining tooth structure for restoration.
• Parent/legal guardian declining informed consent.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak University Faculty of Dentistry

Uşak, Uşak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve ALKIŞ, DDS

  Usak Universty

  STUDY DIRECTOR

• Merve AKAR, DDS

  Usak Universty

  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

Model Details: Participants were assigned to four parallel treatment groups according to their order of presentation to the clinic. The groups differed according to the antibiotic combination (3Mix or 2Mix) and the vehicle used (Macrogol-Propylene Glycol or Normal saline). Participants were followed for 12 months to compare the clinical and radiographic outcomes of the four LSTR protocols.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: November 26, 2024
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)