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Completed

NCT Number: NCT06818578

Success of Lesion Sterilization and Tissue Repair Therapy

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inonu University, Faculty of dentistry

Malatya, 44000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Other names: 3Mix-MP and Alternative 3Mix-MP

Primary outcomes

  1. clinical success

    Time frame: 12 months

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

  2. radiographic success

    Time frame: 12 months

    radiographic criterion was periapical radiolucency.

  3. overall success

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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