Effect Of Different Lining Materials in Stepwise Excavation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Azad University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Sepideh Banava.DDS,MS, Azad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01730287
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Dental Pulp Necrosis
Drug: Control
Drug: Calcium Hydroxide
Drug: Mineral Trioxide Aggregate(MTA)
Drug: CEM cement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial

Resource links provided by NLM:


Further study details as provided by Azad University of Medical Sciences:

Primary Outcome Measures:
  • Pulpal Vitality [ Time Frame: One year ] [ Designated as safety issue: No ]
    Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control
No lining applied in group1.
Drug: Control
The teeth in this group restored only by filling material,without liner application.
Other Name: NO liner applied.
Experimental: CEM cement
CEM cement applied over remained caries in group4.
Drug: CEM cement
CEM cement applied .
Other Name: CEM cement, Yektazist,Iran.
Experimental: Mineral Trioxide Aggregate (MTA)
MTA applied over remained caries in group3.
Drug: Mineral Trioxide Aggregate(MTA)
MTA applied .
Other Name: MTA, white MTA, ProRoot,Dentsply.
Experimental: Calcium Hydroxide
Calcium Hydroxide applied over remained caries in group2.
Drug: Calcium Hydroxide
Calcium Hydroxide paste applied.
Other Name: Calcium Hydroxide paste , Dycal,Dentsply.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730287

Contacts
Contact: Sepideh Banava, Assist-prof 982188882321 sbanava@yahoo.com
Contact: Mohammad Safaie Yazdi, Dentist 00989123614034 mohammad.safaei@yahoo.com

Locations
Iran, Islamic Republic of
Azad University of Medical Sciences, Dental Branch Recruiting
Tehran, N/A = Not Applicable, Iran, Islamic Republic of, 1517884111
Contact: Sepideh Banava, Assist-Prof    982188882321    sbanava@yahoo.com   
Contact: Mohammad Safaie Yazdi, Dentist    00989123614034    mohammad.safaei@yahoo.com   
Principal Investigator: Sepideh Banava, Assist-Prof         
Sponsors and Collaborators
Azad University of Medical Sciences
Investigators
Study Chair: Sepideh Banava, Assist-Prof Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU
  More Information

No publications provided

Responsible Party: Sepideh Banava.DDS,MS, Assist-Prof, Azad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01730287     History of Changes
Other Study ID Numbers: AZadUMS-
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Azad University of Medical Sciences:
Stepwise Excavation
Pulpal vitality
Deep caries lesions
Clinical symptoms
Radiographic evaluation

Additional relevant MeSH terms:
Dental Pulp Necrosis
Dental Pulp Diseases
Necrosis
Pathologic Processes
Stomatognathic Diseases
Tooth Diseases
Calcium, Dietary
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014