Success of Lesion Sterilization and Tissue Repair Therapy

NCT06818578 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2022/74
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess the clinical and radiographic success of lesion sterilization and tissue repair (LSTR) therapy with different antibiotic combinations, focusing on evaluating whether the alternative combination of clindamycin instead of minocycline is as effective as the standard 3Mix-MP formulation.

Conditions

Primary Teeth; Pulp Necrosis; Pulpitis - Irreversible

Keywords

lesion sterilization and tissue repair; antibiotics

Outcome Measures

Primary Outcomes (3)

• clinical success

  clinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss.

  12 months

• radiographic success

  radiographic criterion was periapical radiolucency.

  12 months

• overall success

  If at least one of the clinical findings was present, the treatment was considered unsuccessful. However, even if teeth fail radiographically, they are not classified as overall failure if no clinical signs are present.

  12 months

Study Arms (2)

3Mix-MP

EXPERIMENTAL

Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and minocycline (Minoz, 100 mg, Ranbaxy, India)

Procedure: Lesion Sterilization and Tissue Repair Therapy; Drug: Different Antibiotic Combinations

Alternative 3Mix-MP

ACTIVE COMPARATOR

Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and clindamycin (Klindan, 150 mg capsules, BİLİM, Turkiye)

Procedure: Lesion Sterilization and Tissue Repair Therapy; Drug: Different Antibiotic Combinations

Interventions

Lesion Sterilization and Tissue Repair Therapy PROCEDURE

LSTR treatment is a minimally invasive, cost-effective, and easy-to-apply procedure for necrotic primary teeth, with a focus on disinfection with an antibiotic mixture without the need for root canal instrumentation.

3Mix-MP; Alternative 3Mix-MP

Different Antibiotic Combinations DRUG

Clinical and Radiographic Success of Different Antibiotic Combinations (evaluating whether the alternative 3Mix-MP combination of clindamycin instead of minocycline is as effective as the standard 3Mix-MP formulation) in Lesion Sterilization and Tissue Repair Therapy

Also known as: 3Mix-MP and Alternative 3Mix-MP

3Mix-MP; Alternative 3Mix-MP

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Spontaneous pain
• Pain on percussion
• The presence of abnormal or pathological mobility
• The presence of a sinus tract or dentoalveolar abscess
• Widening of the periodontal ligament
• Periradicular radiolucency
• Evidence of external and/or internal resorption.

You may not qualify if:

• Who required infective endocarditis prophylaxis
• Who had used antibiotics in the two weeks prior to treatment
• İndividuals allergic to the medications used in the study
• Teeth with pulp floor perforation
• Advanced internal and/or external root resorption
• Root canal obliteration
• Excessive bone loss in the furcation area involving the permanent tooth follicle
• Teeth with severe coronal destruction, nonrestorable.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University, Faculty of dentistry

Malatya, 44000, 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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was a randomized controlled clinical trial that followed the recommendations of the Consolidated Standards of Reporting Trials (CONSORT).

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: September 14, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

TU (1)