Effect Of Different Lining Materials in Stepwise Excavation

Dental Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01730287
• Other study ID #: AZadUMS-
• Status: Recruiting
• Phase: Phase 2
• First received: November 15, 2012
• Last updated: November 20, 2012
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: November 2012
• Source: Azad University of Medical Sciences
• Contact: Sepideh Banava, Assist-prof
• Phone: 982188882321
• Email: sbanava[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Necrosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azad University of Medical Sciences, Dental Branch	Tehran	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulpal Vitality	Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.	One year	No