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Completed

NCT Number: NCT04547764

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

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.

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King Abdulaziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

triple antibiotic paste (TAP)

Drug

root canal treatment of pulpally involved teeth.

Vitapex (calcium hydroxide/iodoform paste)

Drug

root canal treatment of pulpally involved teeth.

Primary outcomes

  1. fissure-exact test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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