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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06818578
Enrollment
58
Registered
2025-02-10
Start date
2022-09-14
Completion date
2024-08-30
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Teeth, Pulpitis - Irreversible, Pulp Necrosis

Keywords

lesion sterilization and tissue repair, antibiotics

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.

Interventions

PROCEDURELesion 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.

DRUGDifferent 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

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical success12 monthsclinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss.
radiographic success12 monthsradiographic criterion was periapical radiolucency.
overall success12 monthsIf 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026