Effect Of Different Lining Materials in Stepwise Excavation

November 20, 2012 updated by: Sepideh Banava.DDS,MS, Azad University of Medical Sciences

Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sepideh Banava, Assist-Prof
  • Phone Number: 982188882321
  • Email: sbanava@yahoo.com

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
    • N/A = Not Applicable
      • Tehran, N/A = Not Applicable, Iran, Islamic Republic of, 1517884111
        • Recruiting
        • Azad University of Medical Sciences, Dental Branch
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sepideh Banava, Assist-Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
No lining applied in group1.
Drug: Control
The teeth in this group restored only by filling material,without liner application.
Other Names:
  • NO liner applied.
Experimental: CEM cement
CEM cement applied over remained caries in group4.
Drug: CEM cement
CEM cement applied .
Other Names:
  • CEM cement, Yektazist,Iran.
Experimental: Mineral Trioxide Aggregate (MTA)
MTA applied over remained caries in group3.
Drug: Mineral Trioxide Aggregate(MTA)
MTA applied .
Other Names:
  • MTA, white MTA, ProRoot,Dentsply.
Experimental: Calcium Hydroxide
Calcium Hydroxide applied over remained caries in group2.
Drug: Calcium Hydroxide
Calcium Hydroxide paste applied.
Other Names:
  • Calcium Hydroxide paste , Dycal,Dentsply.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulpal Vitality
Time Frame: One year
Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azad University of Medical Sciences

Investigators

  • Study Chair: Sepideh Banava, Assist-Prof, Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

November 21, 2012

Last Update Submitted That Met QC Criteria

November 20, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZadUMS-

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Pulp Necrosis

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe