Immunohistochemical Study of Human Teeth Pulp Capped With Mineral Trioxide Aggregate (MTA) and Novel Endodontic Cement (NEC)

NCT01066533 | Terminated Phase 4 DMC

• 1 other identifier: 583
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the response of human dental pulp to capping with MTA and NEC by histology and immunohistochemistry, using fibronectin and tenascin as markers, following 2 weeks and 8 weeks.

Conditions

Direct Pulp Capping

Keywords

MTA; NEC; Immunohistochemistry; fibronectin; tenascin

Outcome Measures

Primary Outcomes (1)

• histologic study of: 1-mean thickness of formed dentinal bridge 2-morphology of formed dentinal bridge 3-intensity of pulp inflammation 4-odontoblastic layer

  2 weeks and 8 weeks

Secondary Outcomes (1)

• expression of Fibronectin and Tenascin by immunohistochemistry on a scale of 1 to 3: (a) 1 equals no staining; (b) 2 equals light-medium staining; (c) 3 equals medium-heavy staining for the marker

  2 weeks and 8 weeks

Study Arms (2)

Mineral Trioxide Aggregate(MTA)

EXPERIMENTAL

MTA is a proper material for direct pulp capping,treatment of tooth perforations,root end filling.It is a safe and biocompatible material,which can induce cementum formation on root surface.In direct pulp capping, MTA can induce dentinal bridge formation on the expose surface to preserve pulp vitality.Although MTA has superior biocompatibility compared with the conventional materials,it has a delayed setting time, poor handling characteristics and off-white color

Other: direct pulp capping and covering the exposed pulp

NEC cement

EXPERIMENTAL

NEC cement is a proper material for direct pulp capping and treatment of tooth perforation. It is a new dental material that combines reasonable biocompatibility of MTA with appropriate setting time,handling characteristics,chemical properties and color.Like MTA, NEC cement can induce dentinal bridge formation in direct pulp capping to preserve pulp vitality.

Other: direct pulp capping and covering the exposed pulp

Interventions

direct pulp capping and covering the exposed pulp OTHER

In this arm 16 premolar teeth scheduled for extraction for orthodontic reasons were used.After signed consent was given by patients,local anesthesia was applied before operative procedures. Operative procedures were performed with rubber dam placement and disinfected with 2% chlorhexidine gluconate. Class I occlusal cavities were prepared with ¼ round carbide burs under air-distilled water cooling. At the exposure site hemorrhage was controlled by sterile cotton pellets, saline and 5.25% NaOCl.In this group MTA was mixed on a slab according to manufacture's instructions.Then MTA was carried with a carrier to exposed pulp and it was packed with a slight pressure by moist cotton pellet to completely cover the exposed pulp.The cavities were sealed immediately with Fuji II glass ionomer.The teeth were then followed and extracted(8 teeth after 2 weeks and 8 teeth after 8 weeks)

Mineral Trioxide Aggregate(MTA)

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients 16-30 year-old
• patients with no systemic disease
• vital mature teeth with closed apex, no caries either clinically or radiographically, and without any restoration
• patients willing to participate in study

You may not qualify if:

• patients not in the range of 16-30 year-old
• patients with systemic disease
• nonvital teeth
• open apex teeth
• teeth with caries or restorations
• patients not willing to participate in study

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

Mashhad university of medical sciences

Mashhad, Khorasan, Iran

Location

Study Officials

• Maryam Javidi, endodontist

  Mashhad University of Medical Sciences

  STUDY DIRECTOR

• Mohamad hasan zarrabi, endodontist

  Mashhad University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: February 10, 2010

Record last verified: 2009-07

Locations

IR (1)