Success of Lesion Sterilization and Tissue Repair Therapy

NCT ID: NCT06818578

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2024-08-30

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.

Detailed Description

All the clinical procedures were carried out by one clinician with 2 years of clinical experience in pediatric dentistry under rubber dam isolation and local anesthesia via mandibular nerve block. (Maxicaine Fort Ampoule, VEM, Turkiye). After the removal of carious tissues, an endodontic cavity was prepared, and infected coronal pulp tissue was removed up to the canal orifices via a sterile round steel bur. A sterile round steel bur was then used to prepare a medication cavity 2 mm deep and 1 mm wide. The root canals were not instrumented, and only the access cavity was irrigated with a 2.5% NaOCl solution. In cases where hemostasis could not be achieved, a sterile cotton pellet soaked in 5% NaOCl was placed in the pulp chamber and left for 1 minute. Once hemostasis was achieved, the endodontic cavity was dried using a sterile, dry cotton pellet. Pastes were then applied to the medication cavity and covered with a glass ionomer cement (Nova Glass II F, Imicryl, Turkiye) and a stainless steel crown (Kids Crown, Shinhung, Seoul, Korea) at the same visit. Clinical and radiographic evaluations were performed at 1, 3, 6, 9, and 12 months. During follow-up, the teeth were assessed on the basis of the following clinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss. The radiographic criterion was periapical radiolucency.

Conditions

Primary Teeth; Pulp Necrosis; Pulpitis - Irreversible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

3Mix-MP

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

Group Type: EXPERIMENTAL

Lesion Sterilization and Tissue Repair Therapy

Intervention Type: 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.

Different Antibiotic Combinations

Intervention Type: 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

Alternative 3Mix-MP

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

Group Type: ACTIVE_COMPARATOR

Lesion Sterilization and Tissue Repair Therapy

Intervention Type: 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.

Different Antibiotic Combinations

Intervention Type: 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

Interventions

Lesion Sterilization and Tissue Repair Therapy

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.

Intervention Type: PROCEDURE

Different Antibiotic Combinations

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

Intervention Type: DRUG

Other Intervention Names

3Mix-MP and Alternative 3Mix-MP

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

rüveyda nur culfa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Inonu University, Faculty of dentistry

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/74

Identifier Type: -

Identifier Source: org_study_id