Success of Lesion Sterilization and Tissue Repair Therapy

Evaluation of the Clinical and Radiographic Success of Different Antibiotic Combinations in Lesion Sterilization and Tissue Repair Therapy for Infected Primary Molar Teeth

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.

Study Overview

• Status: Completed
• Conditions: Pulp Necrosis; Pulpitis - Irreversible; Primary Teeth
• Intervention / Treatment: Procedure: Lesion Sterilization and Tissue Repair Therapy; Drug: Different Antibiotic Combinations

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44000
    • Inonu University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3Mix-MP; 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; 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.; Drug: 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; Other Names: 3Mix-MP and Alternative 3Mix-MP
Active Comparator: 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)	Procedure: 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.; Drug: 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; Other Names: 3Mix-MP and Alternative 3Mix-MP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: antibiotics; lesion sterilization and tissue repair
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Dental Pulp Necrosis; Necrosis; Pulpitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2022/74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No