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A clinical trial to compare the effects of different concentrations of antibiotic paste for treatment of carious and infected lower posterior primary teeth in children

Comparative Evaluation of Lesion Sterilization and Tissue Repair in Pulpally Involved Primary Molars using Modified Triple Antibiotic Paste with Different Concentrations: An In Vivo Interventional Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042944
Enrollment
84
Registered
2022-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: K041- Necrosis of pulp

Interventions

Intervention1: Modified Triple Antibiotic Paste consisting of Ciprofloxacin, Metronidazole and Amoxicillin in three different concentrations 0.5 mg/ml, 2.5 mg/ml and 5 mg/ml: An in vivo interventional

Sponsors

Dr Mainak Das
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with deep caries involving pulp in primary molars, Irreversible pulpitis, Irreversible pulpitis with apical periodontitis, Primary molar with at least two-thirds of the roots, Primary molar with restorable crown structure

Exclusion criteria

Exclusion criteria: Primary molar with dentigerous cyst, Special children with a physical or emotional alteration, Children with systemic diseases, Previous history of allergy to antibiotics used in the study, Caries in primary teeth exhibiting pre-shedding mobility, Carious perforation of floor of primary molar, Molar with more than 2/3rd root resorbed, Molars with gross destruction of alveolar bone, Molar with non restorable crown structure

Design outcomes

Primary

MeasureTime frame
Decrease in pain, swelling and mobility (other than shedding mobility) in primary infected molarsTimepoint: 3, 6 and 12 months

Secondary

MeasureTime frame
Radiographic evidence of decrease in intra radicular radiolucency, continuity of lamina dura and absence of internal resorptionTimepoint: 6 and 12 months

Countries

India

Contacts

Public ContactDr Mainak Das

Guru Nanak Institute of Dental Sciences and Research

dr.shabnam.zahir@gmail.com9830215726

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026