Direct Pulp CappingPhase 4NCT01066533
Immunohistochemical Study of Human Teeth Pulp Capped With Mineral Trioxide Aggregate (MTA) and Novel Endodontic Cement (NEC)
A Phase 4 study testing direct pulp capping and covering the exposed pulp in people with Direct Pulp Capping, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Direct Pulp Capping
- What is being tested?
- direct pulp capping and covering the exposed pulp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histologic and Immunohistochemical Study of Fibronectin and Tenascin in Human Teeth Pulp Capped With MTA and NEC
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.
Read the detailed description
Capping of the exposed pulp is indicated for reversible pulp tissue injury after physical or mechanical trauma in developing or mature teeth.The response to direct pulp capping with materials such as MTA or NEC is the formation of dentin barrier, resulting from the recruitment and proliferation of undifferentiated cells.
Different materials can be used to induce dentinal bridge formation.MTA has been introduced as a proper material to induce dentinal bridge formation,with greater mean thickness of dentinal bridge and less inflammation compared to traditional materials like calcium hydroxide. Although biocompatible, MTA has a poor handling characteristic, delay setting time, off-white color, and it is almost expensive.The Novel Endodontic Cement (NEC) has been introduced to combine reasonable characteristics of MTA with appropriate chemical properties, setting time, color, and handling characteristics.
The extracellular matrix (ECM) of pulp comprises a variety of proteins and polysaccharides, forming a neat network. The ECM components can induce either reactionary or reparative dentin formation. Fibronectin (FN) and tenascin (TNC) are the two major glycoproteins involved in wound healing and odontogenesis.
Fibronectins (FNs) are a class of high molecular weight adhesive proteins composed of two very large subunits. It has a variety of cell functions, such as adhesion, migration, growth, and differentiation. Furthermore FN may be involved in the polarization and migration of odontoblasts.
Tenascin is a large oligomeric glycoprotein of the ECM secreted by fibroblasts and glial cells in tissue cultures. It has also been identified in pulp and more prominent in dentinogenesis. TN has been shown to be important in the differentiation of odontoblasts. Therefore, it may be associated with secondary dentin formation, when pulp cells differentiate into odontoblasts in response to physiologic stimuli.
Although dentin bridge formation has been reported,using different materials such as MTA and NEC in direct pulp cap, but the exact mechanism is not well understood. Immunohistochemistry, using different markers, may be useful in developing the molecules involved in this process.
Moreover,response of dental pulp to different pulp capping materials can be studied,including mean thickness of dentinal bridge, morphology of dentinal bridge, and intensity of pulp inflammation and presence of odontoblast cells.
- Conditions
- Direct Pulp Capping
- Being tested
- direct pulp capping and covering the exposed pulp
- Keywords
- MTA, NEC, Immunohistochemistry, fibronectin, tenascin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct pulp capping and covering the exposed pulpOther
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)
direct pulp capping and covering the exposed pulpOther
In this arm 16 premolar teeth scheduled for extraction for orthodontic reasons were used.All the procedure was carried the same as the other group.But NEC cement was used as pulp capping material.It was mixed with its liquid to provide a dense creamy mixture and then was applied on exposed pulp.the cavities were immediately sealed with Fuji II glass ionomer.The patients were followed and 8 teeth were extracted after 2 weeks and 8 teeth were extracted after 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: direct pulp capping and covering the exposed pulp |
What is being measured
The primary outcome is the main question the study is designed to answer.
histologic study of: 1-mean thickness of formed dentinal bridge 2-morphology of formed dentinal bridge 3-intensity of pulp inflammation 4-odontoblastic layer
Measured: 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
Measured: 2 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionFeb 2010 (estimated)
Why it stopped: immunohistochemistry markers are not recieved yet
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Pulp CappingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Investigators
- Maryam Javidi, endodontist, Study director, Mashhad University of Medical SciencesMohamad hasan zarrabi, endodontist, Study director, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066533
- Sponsor's protocol ID
- 583
- Status last verified
- Jul 2009
- First submitted
- 9 Feb 2010
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic and Immunohistochemical Study of Fibronectin and Tenascin in Human Teeth Pulp Capped With MTA and NEC
- ClinicalTrials.gov ID
- NCT01066533
- Acronym / sponsor ID
- 583
- Conditions
- Direct Pulp Capping
- Keywords
- MTA, NEC, Immunohistochemistry, fibronectin, tenascin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: immunohistochemistry markers are not recieved yet
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (estimated)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Capping of the exposed pulp is indicated for reversible pulp tissue injury after physical or mechanical trauma in developing or mature teeth.The response to direct pulp capping with materials such as MTA or NEC is the formation of dentin barrier, resulting from the recruitment and proliferation of undifferentiated cells.
Different materials can be used to induce dentinal bridge formation.MTA has been introduced as a proper material to induce dentinal bridge formation,with greater mean thickness of dentinal bridge and less inflammation compared to traditional materials like calcium hydroxide. Although biocompatible, MTA has a poor handling characteristic, delay setting time, off-white color, and it is almost expensive.The Novel Endodontic Cement (NEC) has been introduced to combine reasonable characteristics of MTA with appropriate chemical properties, setting time, color, and handling characteristics.
The extracellular matrix (ECM) of pulp comprises a variety of proteins and polysaccharides, forming a neat network. The ECM components can induce either reactionary or reparative dentin formation. Fibronectin (FN) and tenascin (TNC) are the two major glycoproteins involved in wound healing and odontogenesis.
Fibronectins (FNs) are a class of high molecular weight adhesive proteins composed of two very large subunits. It has a variety of cell functions, such as adhesion, migration, growth, and differentiation. Furthermore FN may be involved in the polarization and migration of odontoblasts.
Tenascin is a large oligomeric glycoprotein of the ECM secreted by fibroblasts and glial cells in tissue cultures. It has also been identified in pulp and more prominent in dentinogenesis. TN has been shown to be important in the differentiation of odontoblasts. Therefore, it may be associated with secondary dentin formation, when pulp cells differentiate into odontoblasts in response to physiologic stimuli.
Although dentin bridge formation has been reported,using different materials such as MTA and NEC in direct pulp cap, but the exact mechanism is not well understood. Immunohistochemistry, using different markers, may be useful in developing the molecules involved in this process.
Moreover,response of dental pulp to different pulp capping materials can be studied,including mean thickness of dentinal bridge, morphology of dentinal bridge, and intensity of pulp inflammation and presence of odontoblast cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral Trioxide Aggregate(MTA) | Experimental | Other: direct pulp capping and covering the exposed pulpMTA 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 |
| NEC cement | Experimental | Other: direct pulp capping and covering the exposed pulpNEC 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. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- patients not in the range of 16-30 year-old
- patients with systemic disease
- nonvital teeth
- open apex teeth
- teeth with caries or restorations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct pulp capping and covering the exposed pulpIn 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) | Other | Mineral Trioxide Aggregate(MTA) |
| direct pulp capping and covering the exposed pulpIn this arm 16 premolar teeth scheduled for extraction for orthodontic reasons were used.All the procedure was carried the same as the other group.But NEC cement was used as pulp capping material.It was mixed with its liquid to provide a dense creamy mixture and then was applied on exposed pulp.the cavities were immediately sealed with Fuji II glass ionomer.The patients were followed and 8 teeth were extracted after 2 weeks and 8 teeth were extracted after 8 weeks. | Other | NEC cement |
Primary outcome
histologic study of: 1-mean thickness of formed dentinal bridge 2-morphology of formed dentinal bridge 3-intensity of pulp inflammation 4-odontoblastic layer
Time frame: 2 weeks and 8 weeks
1 secondary outcome
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
Time frame: 2 weeks and 8 weeks
Results and safety
The study was stopped early (reason given: immunohistochemistry markers are not recieved yet). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Javidi, endodontist study director
Mashhad University of Medical Sciences
Mohamad hasan zarrabi, endodontist study director
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing direct pulp capping and covering the exposed pulp in people with Direct Pulp Capping, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: immunohistochemistry markers are not recieved yet). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histologic study of: 1-mean thickness of formed dentinal bridge 2-morphology of formed dentinal bridge 3-intensity of pulp inflammation 4-odontoblastic layer (time frame: 2 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.