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

King Abdulaziz University

Status and phase

Completed

Phase 3

Conditions

Dental Pulp Cavity

Treatments

Drug: Vitapex (calcium hydroxide/iodoform paste)

Drug: triple antibiotic paste (TAP)

Study type

Interventional

Funder types

Other

Identifiers

NCT04547764

067-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

5 to 8 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.