Effect Of Different Lining Materials in Stepwise Excavation

Overview

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 Title of Study: “Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

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.

Interventions

  • Drug: Control
    • The teeth in this group restored only by filling material,without liner application.
  • Drug: Calcium Hydroxide
    • Calcium Hydroxide paste applied.
  • Drug: Mineral Trioxide Aggregate(MTA)
    • MTA applied .
  • Drug: CEM cement
    • CEM cement applied .

Arms, Groups and Cohorts

  • Experimental: Control
    • No lining applied in group1.
  • Experimental: CEM cement
    • CEM cement applied over remained caries in group4.
  • Experimental: Mineral Trioxide Aggregate (MTA)
    • MTA applied over remained caries in group3.
  • Experimental: Calcium Hydroxide
    • Calcium Hydroxide applied over remained caries in group2.

Clinical Trial Outcome Measures

Primary Measures

  • Pulpal Vitality
    • Time Frame: One year
    • Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Azad University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sepideh Banava.DDS,MS, Assist-Prof – Azad University of Medical Sciences
  • Overall Official(s)
    • Sepideh Banava, Assist-Prof, Study Chair, Azad University of Medical Sciences, Dental Branch – Endodontics research center , SBMU
  • Overall Contact(s)
    • Sepideh Banava, Assist-prof, 982188882321, sbanava@yahoo.com

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