Success of Lesion Sterilization and Tissue Repair Therapy

Phase 4

Completed

• Conditions: Pulpitis - Irreversible; Primary Teeth; Pulp Necrosis
• Interventions: Procedure: Lesion Sterilization and Tissue Repair Therapy; Drug: Different Antibiotic Combinations

• Registration Number: NCT06818578
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2022-09-14
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3Mix-MP	Lesion Sterilization and Tissue Repair Therapy	Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and minocycline (Minoz, 100 mg, Ranbaxy, India)
3Mix-MP	Different Antibiotic Combinations	Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and minocycline (Minoz, 100 mg, Ranbaxy, India)
Alternative 3Mix-MP	Lesion Sterilization and Tissue Repair Therapy	Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and clindamycin (Klindan, 150 mg capsules, BİLİM, Turkiye)
Alternative 3Mix-MP	Different Antibiotic Combinations	Metronidazole (Flagyl 500 mg tablets, Sanofi-Aventis, Turkiye), ciprofloxacin (Cipro, 750 mg tablets, Biofarma, Turkiye) and clindamycin (Klindan, 150 mg capsules, BİLİM, Turkiye)

Primary Outcome Measures

Name	Time	Method
clinical success	12 months	clinical criteria: pain, dentoalveolar abscess and/or fistula, and tooth loss.
radiographic success	12 months	radiographic criterion was periapical radiolucency.
overall success	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.

Trial Locations

Locations (1)

Inonu University, Faculty of dentistry; 🇹🇷 Malatya, Turkey