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

Dental Pulp Cavity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547764
• Other study ID #: 067-16
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2020
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Cavity

Intervention

Drug:
• triple antibiotic paste (TAP)
root canal treatment of pulpally involved teeth.
• Vitapex (calcium hydroxide/iodoform paste)
root canal treatment of pulpally involved teeth.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University	Jeddah	Makkah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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