NCT01420718

Brief Summary

The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

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

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

August 19, 2011

Last Update Submit

March 25, 2012

Conditions

Dentin BridgePulpitis

Keywords

partial pulpotomyCvek pulpotomyMTAiRootBPdentin bridge

Outcome Measures

Primary Outcomes (1)

  • dentinal bridge formation

    appearance of the dentinal bridge compared to normal dentin will be assessed under microscope

    six weeks after intervention

Secondary Outcomes (1)

  • inflammatory status of the pulp

    six weeks after intervention

Study Arms (2)

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.

Drug: MTA

iRoot BP

EXPERIMENTAL

Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).

Drug: iRoot BP

Interventions

MTADRUG

partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.

Also known as: White ProRoot MTA
Mineral Trioxide Aggregate
iRoot BPDRUG

Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).

Also known as: Injectable Root Bioaggregate Paste
iRoot BP

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
  • Their parents need to read and sign a fully informed form.
  • They shouldn't have any systematic complication or take any medicine during the period of study.
  • The teeth need to be free of any symptom, caries and decalcification
  • They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
  • The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion.
  • On radiographic examination no apical lucency or PDL widening should be detected.

You may not qualify if:

  • tooth crack
  • tooth filling
  • any caries
  • hypocalcification
  • The teeth showing apical lucency
  • PDL widening on radiography
  • sensitivity to cold, heat or bite
  • The responses beyond the normal limits to pulp vitality testing
  • Any medicine consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azad University, Dental Branch, Tehran, Endodontic department

Tehran, 1946853314, Iran

Location

MeSH Terms

Conditions

Pulpitis

Interventions

PemetrexediRoot BP Plus

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Mahta Fazlyab

    Azad University, Dental Branch, Tehran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post graduate student of Endodontic department, Dental Branch

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

IR(1)