Clinical trial NCT01730287: Effect Of Different Lining Materials in Stepwise Excavation
Official title: Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dental Pulp Necrosis
Keywords: Stepwise Excavation
Pulpal vitality
Deep caries lesions
Clinical symptoms
Radiographic evaluation
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulpal Vitality
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azad University of Medical Sciences, Dental Branch
state: N/A = Not Applicable
Study officials:
affiliation: Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU
name: Sepideh Banava, Assist-Prof
role: STUDY_CHAIR
References: