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Effect Of Different Lining Materials in Stepwise Excavation

NCT ID: NCT01730287

Last Updated: 2012-11-21

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-05-31

Brief Summary

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Deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root Canal Therapy (RCT).

Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp Capping (IPC), in this technique only the central infected part of the caries is removed in first visit and the rest of the caries will be lined by a suitable material to suppress the remained cariogenic biomass and seal the cavity. This will help the pulp to defend and survive. After a period, the cavity is re-opened and the rest of the caries which is darker, harder and with less bacteria will be removed and the tooth is restored permanently.The aim of this study was to compare the effect of different lining materials in clinical and radiographical symptoms in stepwise excavation without re-enter after one year.

Detailed Description

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In this randomized clinical trial of 4 lining materials have been applied in deep caries teeth in stepwise excavation. The common material which is applied as a liner over the remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility of this liner over time which could interact with sealing of the cavity in long term. It seems that a material with antibacterial activity, good sealing ability and suitable mechanical properties could cause SE be done efficiently with good prognosis.

MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good antibacterial effect like CH with sealing ability that is proposed to be similar to MTA according to its double sealing property. CEM cement has been suggested as a suitable material in pulp capping of permanent molars with irreversible pulpitis.

Conditions

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Dental Pulp Necrosis

Keywords

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Stepwise Excavation Pulpal vitality Deep caries lesions Clinical symptoms Radiographic evaluation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

No lining applied in group1.

Group Type EXPERIMENTAL

Control

Intervention Type DRUG

The teeth in this group restored only by filling material,without liner application.

CEM cement

CEM cement applied over remained caries in group4.

Group Type EXPERIMENTAL

CEM cement

Intervention Type DRUG

CEM cement applied .

Mineral Trioxide Aggregate (MTA)

MTA applied over remained caries in group3.

Group Type EXPERIMENTAL

Mineral Trioxide Aggregate(MTA)

Intervention Type DRUG

MTA applied .

Calcium Hydroxide

Calcium Hydroxide applied over remained caries in group2.

Group Type EXPERIMENTAL

Calcium Hydroxide

Intervention Type DRUG

Calcium Hydroxide paste applied.

Interventions

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Control

The teeth in this group restored only by filling material,without liner application.

Intervention Type DRUG

Calcium Hydroxide

Calcium Hydroxide paste applied.

Intervention Type DRUG

Mineral Trioxide Aggregate(MTA)

MTA applied .

Intervention Type DRUG

CEM cement

CEM cement applied .

Intervention Type DRUG

Other Intervention Names

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NO liner applied. Calcium Hydroxide paste , Dycal,Dentsply. MTA, white MTA, ProRoot,Dentsply. CEM cement, Yektazist,Iran.

Eligibility Criteria

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Inclusion Criteria

A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal , instantaneous , night pain

Exclusion Criteria

Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sepideh Banava.DDS,MS

Assist-Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sepideh Banava, Assist-Prof

Role: STUDY_CHAIR

Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU

Locations

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Azad University of Medical Sciences, Dental Branch

Tehran, N/A = Not Applicable, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Sepideh Banava, Assist-prof

Role: CONTACT

Phone: 982188882321

Email: [email protected]

Mohammad Safaie Yazdi, Dentist

Role: CONTACT

Phone: 00989123614034

Email: [email protected]

Facility Contacts

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Sepideh Banava, Assist-Prof

Role: primary

Mohammad Safaie Yazdi, Dentist

Role: backup

Other Identifiers

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AZadUMS-

Identifier Type: -

Identifier Source: org_study_id