NCT00881491

Brief Summary

The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Apr 2009

Longer than P75 for early_phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

5.8 years

First QC Date

April 13, 2009

Last Update Submit

February 4, 2016

Conditions

Pulp Necrosis

Keywords

Regeneration (revascularization) of dental pulpImmature permanent tooth with a diagnosis of

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.

    1. st radiograph taken at 1 month post-procedure completion 2. nd radiograph taken at 3 month post-procedure completion 3. rd radiograph taken at 6 month post-procedure completion

    3 measurements over 6 months

Secondary Outcomes (1)

  • The secondary outcomes will be lack of clinical symptoms and crown staining.

    assessed over the 6 month study period

Study Arms (3)

Group A

EXPERIMENTAL

Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole

Drug: Double Antibiotic Paste

Group B

EXPERIMENTAL

Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline

Drug: Triple Antibiotic Paste

Group C

ACTIVE COMPARATOR

Group C - Mineral trioxide aggregate: used as an apical barrier

Drug: Mineral Trioxide Aggregate

Interventions

Double Antibiotic PasteDRUG

ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.

Group A
Triple Antibiotic PasteDRUG

ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.

Group B
Mineral Trioxide AggregateDRUG

standard material providing an apical barrier

Group C

Eligibility Criteria

Age7 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of pulpal necrosis with apical periodontitis
  • patients 7-60 years of age
  • maxillary or mandibular restorable single rooted immature permanent tooth with open apices
  • acceptance of treatment plan with revascularization procedure
  • healthy patient (ASA Class I or II physical status) with no systemic health problems

You may not qualify if:

  • non-restorable teeth
  • patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
  • child subjects unable to give assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth M Hargreaves, DDS, PhD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Endodontics

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

No data to be shared

Locations

US(1)