NCT01468480

Brief Summary

Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2010

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, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

November 4, 2011

Last Update Submit

November 8, 2011

Conditions

Dental Pulp Exposure

Keywords

direct pulp cappingMTASingle visit pulp capMultical

Outcome Measures

Primary Outcomes (1)

  • histologic findings - inflammation of the pulp

    According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points.

    6weeks

Secondary Outcomes (1)

  • histologic findings - formation of the dentinal bridge

    6 weeks

Study Arms (4)

Pro Root MTA- standard method

EXPERIMENTAL

application of MTA in second group and 24 hour interval before restoration

Drug: Pro Root MTA

Pro Root MTA- single visit

EXPERIMENTAL

Intervention/Control application of MTA in third group and 15 minute interval before restoration

Drug: Pro Root MTA- single visit

MultiCal / LimeLite

EXPERIMENTAL

application of Multical in forth group

Drug: MultiCal

Dycal

ACTIVE COMPARATOR

application of Dycal in first group as a pulp dressing agent

Drug: Dycal

Interventions

Pro Root MTADRUG

application of MTA in second group and 24 hour interval before restoration

Also known as: Mineral Trioxide Aggregate
Pro Root MTA- standard method
Pro Root MTA- single visitDRUG

application of MTA in third group and 15 minute interval before restoration

Also known as: Mineral Trioxide Aggregate
Pro Root MTA- single visit
MultiCalDRUG

application of Multical in forth group as a pulp dressing agent

Also known as: Hard set calcium hydroxide paste
MultiCal / LimeLite
DycalDRUG

application of Dycal in first group as a pulp dressing agent

Also known as: chemical set calcium hydroxide
Dycal

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients aging from 10 to 16
  • Patients who need to extract 4 premolars for orthodontic purposes
  • the teeth should be free of caries and clinical symptoms
  • Through thermal tests and radiographic examination absence of any pathology is confirmed.
  • Periapical radiographs demonstrating absence of any pathology
  • no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds.
  • Absence of any systematic disorder
  • No consumption of drugs of any kind
  • All patients and their parents need to sign a fully informed consent.

You may not qualify if:

  • If any of the teeth shows caries, restoration, crack or hypocalcification
  • presence of any periapical pathosis
  • Teeth that seem sensitive to cold, hot, percussion or pressure
  • any systematic disorder
  • consumption of drugs of any kind.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahta Fazlyab

Tehran, Tehran Province, 1946853314, Iran

Location

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

mineral trioxide aggregateDycal

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Mahta Fazlyab, Resident

    Fazlyab Mahta

    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 endodontics

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 9, 2011

Study Start

June 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

IR(1)