NCT03507556

Brief Summary

This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
56mo left

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress78%
Jun 2010Dec 2030

Study Start

First participant enrolled

June 28, 2010

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

11.4 years

First QC Date

April 15, 2018

Last Update Submit

February 21, 2020

Conditions

Revascularization

Keywords

immature teeth, necrotic teeth

Outcome Measures

Primary Outcomes (1)

  • complete healing

    Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development

    from start of intervention up to 100 months.

Study Arms (1)

Triple paste and induced bleeding

EXPERIMENTAL

The triple paste is a mixture of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol will be used and next visit intracanal bleeding will be induced

Procedure: Triple paste and induced bleedingDrug: Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

Interventions

Triple paste and induced bleedingPROCEDURE
Triple paste and induced bleeding
Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycolDRUG

triple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

Triple paste and induced bleeding

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
  • An immature/open apex.
  • Tooth does not need post and core restoration.
  • Medically healthy patients with no known allergy to used materials.

You may not qualify if:

  • Medically compromised patient,
  • Teeth with periodontal involvement
  • Teeth with vertical root fractures,
  • Non-restorable teeth,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental health center

Irbid, Jordan

Location

MeSH Terms

Interventions

Zinc OxideCiprofloxacin

Intervention Hierarchy (Ancestors)

OxidesOxygen CompoundsInorganic ChemicalsZinc CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Revascularization for immature necrotic permanent teeth with apical periodontitis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2018

First Posted

April 25, 2018

Study Start

June 28, 2010

Primary Completion

November 1, 2021

Study Completion (Estimated)

December 1, 2030

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

JO(1)