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

Phase 3

Completed

• Conditions: Dental Pulp Cavity
• Interventions: Drug: triple antibiotic paste (TAP); Drug: Vitapex (calcium hydroxide/iodoform paste)

• Registration Number: NCT04547764
• Lead Sponsor: King Abdulaziz University

Brief 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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30
• Study First Submitted: 2020-07-11
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:

• badly decayed with signs of irreversible pulpitis,
• necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,

All the teeth included, had physiological root resorption of less than one third of the root.

Exclusion Criteria

• Teeth showing radiographic evidence of excessive internal or external root resorption,
• perforated pulpal floor,
• excessive bone loss in furcation area involving the underlying tooth germ,
• non- restorable teeth were excluded from the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP group	triple antibiotic paste (TAP)	-
Vitapex group	Vitapex (calcium hydroxide/iodoform paste)	-

Primary Outcome Measures

Name	Time	Method
fissure-exact test	up to 12 months	The success rate of case and control groups, at 6 and 12 months follow-ups, are compared by Fissure-Exact Test.

Trial Locations

Locations (1)

King Abdulaziz University; 🇸🇦 Jeddah, Makkah, Saudi Arabia