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Human Pulpal Response After Pulp Capping With Four Different Agents

NCT ID: NCT01468480

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation \& dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.

Conditions

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Dental Pulp Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pro Root MTA- standard method

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

Group Type EXPERIMENTAL

Pro Root MTA

Intervention Type DRUG

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

Pro Root MTA- single visit

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

Group Type EXPERIMENTAL

Pro Root MTA- single visit

Intervention Type DRUG

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

MultiCal / LimeLite

application of Multical in forth group

Group Type EXPERIMENTAL

MultiCal

Intervention Type DRUG

application of Multical in forth group as a pulp dressing agent

Dycal

application of Dycal in first group as a pulp dressing agent

Group Type ACTIVE_COMPARATOR

Dycal

Intervention Type DRUG

application of Dycal in first group as a pulp dressing agent

Interventions

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Pro Root MTA

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

Intervention Type DRUG

Pro Root MTA- single visit

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

Intervention Type DRUG

MultiCal

application of Multical in forth group as a pulp dressing agent

Intervention Type DRUG

Dycal

application of Dycal in first group as a pulp dressing agent

Intervention Type DRUG

Other Intervention Names

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Mineral Trioxide Aggregate Mineral Trioxide Aggregate Hard set calcium hydroxide paste chemical set calcium hydroxide

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Islamic Azad University, Sanandaj

OTHER

Sponsor Role lead

Responsible Party

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Mahta Fazlyab

Post graduate student of endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahta Fazlyab, Resident

Role: PRINCIPAL_INVESTIGATOR

Fazlyab Mahta

Locations

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Mahta Fazlyab

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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p/261/d

Identifier Type: -

Identifier Source: org_study_id