Dentin BridgePhase 2/3NCT01420718
Partial Pulpotomy on Caries Free Human Teeth
A Phase 2/3 study testing MTA and iRoot BP in people with Dentin Bridge and Pulpitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Bridge, Pulpitis
- What is being tested?
- MTA and iRoot BP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIran
- Study dates
- Jun 2011to Mar 2012
- Phase
- Phase 2/3
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
- Their parents need to read and sign a fully informed form.
- They shouldn't have any systematic complication or take any medicine during the period of study.
- The teeth need to be free of any symptom, caries and decalcification
- They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
- The teeth need to be free of mobility or swelling in the surrounding soft tissues and any sensitivity on palpation or percussion.
- On radiographic examination no apical lucency or PDL widening should be detected.
Who cannot join
- tooth crack
- tooth filling
- any caries
- hypocalcification
- The teeth showing apical lucency
- PDL widening on radiography
Show all 9Show fewer
- sensitivity to cold, heat or bite
- The responses beyond the normal limits to pulp vitality testing
- Any medicine consumption
Trial locations and contacts
1 site in 1 country.
Iran1 site
Azad University, Dental Branch, Tehran, Endodontic department
Tehran, 1946853314
About this study
Official title: Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial
The purpose of this study is to compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.
Read the detailed description
This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries free premolar teeth from fifteen patients assigned for orthodontic extraction will be included. Participants including major eligibility criteria: Their parents need to sign an informed form, Patients shouldn't have any systematic complication, The teeth should be free of any symptom, caries and decalcification and should reveal a normal response to pulp sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on palpation or percussion should be present. Intervention: A class one cavity will be prepared and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal pulp will be removed. Then the exposure site will be covered using two pulpotomy agents: White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be extracted after radiographic and clinical examination to find any sign of swelling, abscess or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel defect formation. The underlying pulp will be assessed and graded according to the degree of inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our criteria are based on ISO 7405.
- Conditions
- Dentin Bridge, Pulpitis
- Being tested
- MTA, iRoot BP
- Keywords
- partial pulpotomy, Cvek pulpotomy, MTA, iRootBP, dentin bridge
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTADrug
Also called White ProRoot MTA
partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
iRoot BPDrug
Also called Injectable Root Bioaggregate Paste
Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).
| Study group | Role | What they receive |
|---|---|---|
| Mineral Trioxide Aggregate | Active comparator | partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Receives: Drug: MTA |
| iRoot BP | Experimental | Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste). Receives: Drug: iRoot BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
dentinal bridge formation
appearance of the dentinal bridge compared to normal dentin will be assessed under microscope
Measured: six weeks after intervention
Secondary outcomes (1)
inflammatory status of the pulp
microscopic evaluation : inflammatory cell count and their distribution
Measured: six weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin BridgeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahta Fazlyab, Islamic Azad University, Sanandaj
- Investigators
- Mahta Fazlyab, Principal investigator, Azad University, Dental Branch, Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420718
- Sponsor's protocol ID
- p/439/d
- Other IDs
- IRCT201102145804N2
- Status last verified
- Mar 2012
- First submitted
- 19 Aug 2011
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Pulpotomy on Caries Free Human Teeth Using iRootBP and White ProRoot MTA: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01420718
- Acronym / sponsor ID
- p/439/d
- Conditions
- Dentin Bridge, Pulpitis
- Keywords
- partial pulpotomy, Cvek pulpotomy, MTA, iRootBP, dentin bridge
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Aug 2011 (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 compare the human pulp response to partial pulpotomy using White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.
Detailed description
This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries free premolar teeth from fifteen patients assigned for orthodontic extraction will be included. Participants including major eligibility criteria: Their parents need to sign an informed form, Patients shouldn't have any systematic complication, The teeth should be free of any symptom, caries and decalcification and should reveal a normal response to pulp sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on palpation or percussion should be present. Intervention: A class one cavity will be prepared and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal pulp will be removed. Then the exposure site will be covered using two pulpotomy agents: White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be extracted after radiographic and clinical examination to find any sign of swelling, abscess or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel defect formation. The underlying pulp will be assessed and graded according to the degree of inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our criteria are based on ISO 7405.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral Trioxide Aggregate | Active comparator | Drug: MTApartial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. |
| iRoot BP | Experimental | Drug: iRoot BPPartial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste). |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients who are assigned to extract two premolar teeth in one jaw for orthodontic treatment plan.
- Their parents need to read and sign a fully informed form.
- They shouldn't have any systematic complication or take any medicine during the period of study.
- The teeth need to be free of any symptom, caries and decalcification
- They should give a normal response to pulp sensitivity tests (cold test) compared to the control tooth on the same quadrant.
Key exclusion criteria (9 listed)
- tooth crack
- tooth filling
- any caries
- hypocalcification
- The teeth showing apical lucency
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 |
|---|---|---|
| MTAAlso: White ProRoot MTApartial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. | Drug | Mineral Trioxide Aggregate |
| iRoot BPAlso: Injectable Root Bioaggregate PastePartial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste). | Drug | iRoot BP |
Primary outcome
dentinal bridge formation
Time frame: six weeks after intervention
appearance of the dentinal bridge compared to normal dentin will be assessed under microscope
1 secondary outcome
inflammatory status of the pulp
Time frame: six weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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A Comparative Clinical Study Assessing Dentin Thickness and Discoloration in Deep Carious Lesions Treated With Biodentine Alone Versus Diode Laser Pre-treatment Followed by Biodentine
Patients With Deep Carious Lesions, Deep Caries Lesion of Pemanent Teeth
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This Study Aims to Clinically Assess and Radiographically Measure the Formed Dentin Bridge Over the Pulp, Utilizing Three-dimensional Imaging Following the Application of a Bioactive Restorative System Versus a Conventional Restorative System After Selective Caries Removal to Soft Dentin Over 2
Deep Carious Lesions, Partial Caries Removal
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.
Mahta Fazlyab principal investigator
Azad University, Dental Branch, Tehran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MTA and iRoot BP in people with Dentin Bridge and Pulpitis, run by Islamic Azad University, Sanandaj 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 27 Mar 2012. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dentinal bridge formation (time frame: six weeks after intervention). 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 27 Mar 2012.