Pulpotomy TreatmentPhase 3NCT00802256
Comparative Evaluation of Pulpotomized Primary Molars With Mineral Trioxide Aggregate and New Endodonthic Cement
A Phase 3 study testing pulpotomy in people with Pulpotomy Treatment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy Treatment
- What is being tested?
- pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 3
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Vital pulp exposure of teeth with caries or trauma
- No clinical signs \& symptoms like pain,inflammation
- No radiographic signs \& symptoms like: internal resorption,external resorption, furcation involvement,pulp canal obliteration.
- The restorable tooth
- No dental treatment contraindication
Who cannot join
- Systemic diseases
- Existence of pain,inflammation or sinus tract
- No patient compliance
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Saheed Behesti University for Medical sciences
Tehran
Fatemeh Shekarchi, student, 00989124849179, fshekarchi84@yahoo.com
Dr. Saeed Asgary, professor
About this study
Official title: Comparative Evaluation of Pulpotomized Primary Molars With Mineralized Trioxide Aggregate & New Endodonthic Cement
A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars.
Read the detailed description
Forty patient are selected randomly. Each patient has at least 2 teeth which require pulpotomy treatment. After removing of carious teeth by a low speed round bur and pulp exposure, roof of pulp chamber is removed completely by a high speed 008 fissure bur. Life tissues of pulp are removed by sharp excavator and rinsing with normal salin. Hemostat is achieved and cavity will be cleaned by 0.5% hypo chlorate solution. MTA or NEC material is mixed according to manufacturer instruction and will be placed in pulp chamber and over pulpal canal orifices for at least 1 mm. The light cure glass inomor is also mixed according to manufacturer instruction and is places over the A or B material and cured for 40 minutes. The treated tooth will be restored with a stainless steel crown or amalgam filling material.
- Conditions
- Pulpotomy Treatment
- Being tested
- pulpotomy
- Keywords
- pulpotomy, primary molar teeth, MTA, NEC, CEM, Primary Molar Teeth Which Require Pulpotomy Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
removal of caries and cronal pulp tissue and then restoring of tooth
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | teeth which are treated with Mineral Trioxide Aggregate (MTA) material Receives: Procedure: pulpotomy |
| B | Experimental | teeth which are treated with new Endodontic Cement (NEC) material Receives: Procedure: pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical features and radiographic examination
Measured: 6 monthes and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpotomy TreatmentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Iranian center for endodontic research
- Investigators
- Fatemeh Shekarchi, student, Principal investigator, Saheed Behesti University for Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802256
- Sponsor's protocol ID
- 63sh138
- Status last verified
- Apr 2009
- First submitted
- 3 Dec 2008
- Last updated
- 10 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Pulpotomized Primary Molars With Mineralized Trioxide Aggregate & New Endodonthic Cement
- ClinicalTrials.gov ID
- NCT00802256
- Acronym / sponsor ID
- 63sh138
- Conditions
- Pulpotomy Treatment
- Keywords
- pulpotomy, primary molar teeth, MTA, NEC, CEM, Primary Molar Teeth Which Require Pulpotomy Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Iranian center for endodontic research
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 4 Dec 2008 (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.
A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars.
Detailed description
Forty patient are selected randomly. Each patient has at least 2 teeth which require pulpotomy treatment. After removing of carious teeth by a low speed round bur and pulp exposure, roof of pulp chamber is removed completely by a high speed 008 fissure bur. Life tissues of pulp are removed by sharp excavator and rinsing with normal salin. Hemostat is achieved and cavity will be cleaned by 0.5% hypo chlorate solution. MTA or NEC material is mixed according to manufacturer instruction and will be placed in pulp chamber and over pulpal canal orifices for at least 1 mm. The light cure glass inomor is also mixed according to manufacturer instruction and is places over the A or B material and cured for 40 minutes. The treated tooth will be restored with a stainless steel crown or amalgam filling material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: pulpotomyteeth which are treated with Mineral Trioxide Aggregate (MTA) material |
| B | Experimental | Procedure: pulpotomyteeth which are treated with new Endodontic Cement (NEC) material |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Vital pulp exposure of teeth with caries or trauma
- No clinical signs \& symptoms like pain,inflammation
- No radiographic signs \& symptoms like: internal resorption,external resorption, furcation involvement,pulp canal obliteration.
- The restorable tooth
- No dental treatment contraindication
Key exclusion criteria (3 listed)
- Systemic diseases
- Existence of pain,inflammation or sinus tract
- No patient compliance
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 |
|---|---|---|
| pulpotomyremoval of caries and cronal pulp tissue and then restoring of tooth | Procedure or surgery | A, B |
Primary outcome
Clinical features and radiographic examination
Time frame: 6 monthes and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2009.
Related trials for Pulpotomy Treatment
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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
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Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis and Post Operative Pain
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Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
Pulpotomies Primary Teeth
Enrolling by invitation
Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth.
Post-operative Pain, Vital Pulp Therapy
Active, not recruiting
Comparison of Sodium Hypochlorite Gel and Solution With and Without Nanoparticles for Postoperative Pain After Pulpotomy in Permanent Mandibular Molars
Vital Pulp Therapies, Pulpotomy
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.
Fatemeh Shekarchi, student principal investigator
Saheed Behesti University for 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 3 study testing pulpotomy in people with Pulpotomy Treatment, run by Shahid Beheshti 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatemeh Shekarchi, student (00989124849179, fshekarchi84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical features and radiographic examination (time frame: 6 monthes and one year). 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 Apr 2009.