A Phase 2 interventional study of Control and Calcium Hydroxide in Dental Pulp Necrosis, sponsored by Azad University of Medical Sciences. Status unknown at 1 site in Iran. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-21.
Sponsored by Azad University of Medical Sciences · Phase 2, Interventional, and Treatment
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.
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.
154 studies on the registry are indexed under Dental Pulp Necrosis; 40 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 144 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Azad University of Medical Sciences is the lead sponsor of 11 studies on the registry; none are open to participants now.
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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
No lining applied in group1.
Drug: Control
CEM cement applied over remained caries in group4.
Drug: CEM cement
MTA applied over remained caries in group3.
Drug: Mineral Trioxide Aggregate(MTA)
Calcium Hydroxide applied over remained caries in group2.
Drug: Calcium Hydroxide
The teeth in this group restored only by filling material,without liner application.
Also known as: NO liner applied.
Calcium Hydroxide paste applied.
Also known as: Calcium Hydroxide paste , Dycal,Dentsply.
MTA applied .
Also known as: MTA, white MTA, ProRoot,Dentsply.
CEM cement applied .
Also known as: CEM cement, Yektazist,Iran.
Pulpal Vitality
Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
Time frame: One year
The record gives a start of May 2010, a primary completion of Dec 2012 and a completion of May 2013. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Calcium Hydroxide · Mineral trioxide aggregate
Azad University of Medical Sciences