NCT04547764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

July 11, 2020

Last Update Submit

September 8, 2020

Conditions

Dental Pulp Cavity

Keywords

Deciduous teeth, endodontic treatment, primary molars, pulpectomy.

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

TAP group

EXPERIMENTAL
Drug: triple antibiotic paste (TAP)

Vitapex group

ACTIVE COMPARATOR
Drug: Vitapex (calcium hydroxide/iodoform paste)

Interventions

triple antibiotic paste (TAP)DRUG

root canal treatment of pulpally involved teeth.

TAP group
Vitapex (calcium hydroxide/iodoform paste)DRUG

root canal treatment of pulpally involved teeth.

Vitapex group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries

Interventions

calcium hydroxide, iodoform, silicone oil drug combinationCalcium Hydroxide

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • heba sabbagh, PhD

    Assistant Professor, Department of Pediatric Dentistry King Abdulaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 11, 2020

First Posted

September 14, 2020

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations

SA(1)