Success of Lesion Sterilization and Tissue Repair Therapy

Inonu University

Status and phase: Completed; Phase 4

Conditions: Primary Teeth; Pulpitis - Irreversible; Pulp Necrosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06818578

2022/74

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

3Mix-MP

Experimental group

Description:

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

Treatment:

Drug: Different Antibiotic Combinations

Procedure: Lesion Sterilization and Tissue Repair Therapy

Alternative 3Mix-MP

Active Comparator group

Description:

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

Treatment:

Drug: Different Antibiotic Combinations

Procedure: Lesion Sterilization and Tissue Repair Therapy