Skip to content

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04547764
Enrollment
54
Registered
2020-09-14
Start date
2017-06-01
Completion date
2018-12-30
Last updated
2020-09-14

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

Conditions

Dental Pulp Cavity

Keywords

Deciduous teeth, endodontic treatment, primary molars, pulpectomy.

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.

Interventions

root canal treatment of pulpally involved teeth.

DRUGVitapex (calcium hydroxide/iodoform paste)

root canal treatment of pulpally involved teeth.

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fissure-exact testup to 12 monthsThe success rate of case and control groups, at 6 and 12 months follow-ups, are compared by Fissure-Exact Test.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026