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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Pulp Cavity

Intervention / Treatment
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* Drug: triple antibiotic paste (TAP)
* Drug: Vitapex (calcium hydroxide/iodoform paste)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP group<br> | Drug: triple antibiotic paste (TAP)<br>* root canal treatment of pulpally involved teeth.<br>|
| Active Comparator: Vitapex group<br> | Drug: Vitapex (calcium hydroxide/iodoform paste)<br>* root canal treatment of pulpally involved teeth.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deciduous teeth, endodontic treatment, primary molars, pulpectomy.