Effect Of Different Lining Materials in Stepwise Excavation
Primary Purpose
Dental Pulp Necrosis
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Control
Calcium Hydroxide
Mineral Trioxide Aggregate(MTA)
CEM cement
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Necrosis focused on measuring Stepwise Excavation, Pulpal vitality, Deep caries lesions, Clinical symptoms, Radiographic evaluation
Eligibility 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
Sites / Locations
- Azad University of Medical Sciences, Dental BranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Control
CEM cement
Mineral Trioxide Aggregate (MTA)
Calcium Hydroxide
Arm Description
No lining applied in group1.
CEM cement applied over remained caries in group4.
MTA applied over remained caries in group3.
Calcium Hydroxide applied over remained caries in group2.
Outcomes
Primary Outcome Measures
Pulpal Vitality
Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
Secondary Outcome Measures
Full Information
NCT ID
NCT01730287
First Posted
November 15, 2012
Last Updated
November 20, 2012
Sponsor
Azad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01730287
Brief Title
Effect Of Different Lining Materials in Stepwise Excavation
Official Title
Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necrosis
Keywords
Stepwise Excavation, Pulpal vitality, Deep caries lesions, Clinical symptoms, Radiographic evaluation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
No lining applied in group1.
Arm Title
CEM cement
Arm Type
Experimental
Arm Description
CEM cement applied over remained caries in group4.
Arm Title
Mineral Trioxide Aggregate (MTA)
Arm Type
Experimental
Arm Description
MTA applied over remained caries in group3.
Arm Title
Calcium Hydroxide
Arm Type
Experimental
Arm Description
Calcium Hydroxide applied over remained caries in group2.
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
NO liner applied.
Intervention Description
The teeth in this group restored only by filling material,without liner application.
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide
Other Intervention Name(s)
Calcium Hydroxide paste , Dycal,Dentsply.
Intervention Description
Calcium Hydroxide paste applied.
Intervention Type
Drug
Intervention Name(s)
Mineral Trioxide Aggregate(MTA)
Other Intervention Name(s)
MTA, white MTA, ProRoot,Dentsply.
Intervention Description
MTA applied .
Intervention Type
Drug
Intervention Name(s)
CEM cement
Other Intervention Name(s)
CEM cement, Yektazist,Iran.
Intervention Description
CEM cement applied .
Primary Outcome Measure Information:
Title
Pulpal Vitality
Description
Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sepideh Banava, Assist-prof
Phone
982188882321
Email
sbanava@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Safaie Yazdi, Dentist
Phone
00989123614034
Email
mohammad.safaei@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sepideh Banava, Assist-Prof
Organizational Affiliation
Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU
Official's Role
Study Chair
Facility Information:
Facility Name
Azad University of Medical Sciences, Dental Branch
City
Tehran
State/Province
N/A = Not Applicable
ZIP/Postal Code
1517884111
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sepideh Banava, Assist-Prof
Phone
982188882321
Email
sbanava@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammad Safaie Yazdi, Dentist
Phone
00989123614034
Email
mohammad.safaei@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sepideh Banava, Assist-Prof
12. IPD Sharing Statement
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Effect Of Different Lining Materials in Stepwise Excavation
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