NCT04547764

Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex in Primary Molars.

Clinical and Radiographic Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex Pulpectomy in Non-vital Primary Molars.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.

Detailed description

This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.

Conditions

• Dental Pulp Cavity

Interventions

Type	Name	Description
DRUG	triple antibiotic paste (TAP)	root canal treatment of pulpally involved teeth.
DRUG	Vitapex (calcium hydroxide/iodoform paste)	root canal treatment of pulpally involved teeth.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-12-01
• Completion: 2018-12-30
• First posted: 2020-09-14
• Last updated: 2020-09-14

Locations

1 site across 1 country: Saudi Arabia