Effect Of Different Lining Materials in Stepwise Excavation
|ClinicalTrials.gov Identifier: NCT01730287|
Recruitment Status : Unknown
Verified November 2012 by Sepideh Banava.DDS,MS, Azad University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : November 21, 2012
Last Update Posted : November 21, 2012
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 or disease||Intervention/treatment||Phase|
|Dental Pulp Necrosis||Drug: Control Drug: Calcium Hydroxide Drug: Mineral Trioxide Aggregate(MTA) Drug: CEM cement||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||May 2013|
No lining applied in group1.
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.
- Pulpal Vitality [ Time Frame: One year ]Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730287
|Contact: Sepideh Banava, Assistfirstname.lastname@example.org|
|Contact: Mohammad Safaie Yazdi, Dentistemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Mohammad Safaie Yazdi, Dentist 00989123614034 email@example.com|
|Principal Investigator: Sepideh Banava, Assist-Prof|
|Study Chair:||Sepideh Banava, Assist-Prof||Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU|