Effect Of Different Lining Materials in Stepwise Excavation

Azad University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Dental Pulp Necrosis

Treatments: Drug: Calcium Hydroxide; Drug: CEM cement; Drug: Control; Drug: Mineral Trioxide Aggregate(MTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01730287

AZadUMS-

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Control

Experimental group

Description:

No lining applied in group1.

Treatment:

Drug: Control

CEM cement

Experimental group

Description:

CEM cement applied over remained caries in group4.

Treatment:

Drug: CEM cement

Mineral Trioxide Aggregate (MTA)

Experimental group

Description:

MTA applied over remained caries in group3.

Treatment:

Drug: Mineral Trioxide Aggregate(MTA)

Calcium Hydroxide

Experimental group

Description:

Calcium Hydroxide applied over remained caries in group2.

Treatment:

Drug: Calcium Hydroxide