Effect Of Different Lining Materials in Stepwise Excavation

Phase 2

• Conditions: Dental Pulp Necrosis
• Interventions: Drug: Control; Drug: CEM cement; Drug: Mineral Trioxide Aggregate(MTA); Drug: Calcium Hydroxide

• Registration Number: NCT01730287
• Lead Sponsor: Azad University of Medical Sciences

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.

Study Timeline

• Study Start: 2010-05
• Status Verified: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-20
• Last Update Submitted: 2012-11-20
• Study First Posted: 2012-11-21
• Last Update Posted: 2012-11-21
• Primary Completion: 2012-12
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	No lining applied in group1.
CEM cement	CEM cement	CEM cement applied over remained caries in group4.
Mineral Trioxide Aggregate (MTA)	Mineral Trioxide Aggregate(MTA)	MTA applied over remained caries in group3.
Calcium Hydroxide	Calcium Hydroxide	Calcium Hydroxide applied over remained caries in group2.

Primary Outcome Measures

Name	Time	Method
Pulpal Vitality	One year	Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.

Trial Locations

Locations (1)

Azad University of Medical Sciences, Dental Branch; 🇮🇷 Tehran, N/A = Not Applicable, Iran, Islamic Republic of