Effect Of Different Lining Materials in Stepwise Excavation

NCT01730287 | Unknown Phase 2 DMC

• 1 other identifier: AZadUMS-
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pulp Necrosis

Keywords

Stepwise Excavation; Pulpal vitality; Deep caries lesions; Clinical symptoms; Radiographic evaluation

Outcome Measures

Primary Outcomes (1)

• Pulpal Vitality

  Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.

  One year

Study Arms (4)

Control

EXPERIMENTAL

No lining applied in group1.

Drug: Control

CEM cement

EXPERIMENTAL

CEM cement applied over remained caries in group4.

Drug: CEM cement

Mineral Trioxide Aggregate (MTA)

EXPERIMENTAL

MTA applied over remained caries in group3.

Drug: Mineral Trioxide Aggregate(MTA)

Calcium Hydroxide

EXPERIMENTAL

Calcium Hydroxide applied over remained caries in group2.

Drug: Calcium Hydroxide

Interventions

Control DRUG

The teeth in this group restored only by filling material,without liner application.

Also known as: NO liner applied.

Control

Calcium Hydroxide DRUG

Calcium Hydroxide paste applied.

Also known as: Calcium Hydroxide paste , Dycal,Dentsply.

Calcium Hydroxide

Mineral Trioxide Aggregate(MTA) DRUG

MTA applied .

Also known as: MTA, white MTA, ProRoot,Dentsply.

Mineral Trioxide Aggregate (MTA)

CEM cement DRUG

CEM cement applied .

Also known as: CEM cement, Yektazist,Iran.

CEM cement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal , instantaneous , night pain

You may not qualify if:

• Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening

Sponsors & Collaborators

• Azad University of Medical Sciences: lead

Study Sites (1)

Azad University of Medical Sciences, Dental Branch

Tehran, N/A = Not Applicable, 1517884111, Iran

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Calcium Hydroxide; Dycal; CMW cement; mineral trioxide aggregate; Pemetrexed; calcium-enriched mixture cement

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Sepideh Banava, Assist-Prof

  Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU

  STUDY CHAIR

Central Study Contacts

Sepideh Banava, Assist-prof

CONTACT

982188882321; sbanava@yahoo.com

Mohammad Safaie Yazdi, Dentist

CONTACT

00989123614034; mohammad.safaei@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist-Prof

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

IR (1)