Dental Pulp ExposurePhase 2/3NCT01468480
Human Pulpal Response After Pulp Capping With Four Different Agents
A Phase 2/3 study testing Pro Root MTA, Pro Root MTA- single visit and MultiCal in people with Dental Pulp Exposure, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Exposure
- What is being tested?
- Pro Root MTA, Pro Root MTA- single visit and MultiCal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- Jun 2010to Mar 2011
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aging from 10 to 16
- Patients who need to extract 4 premolars for orthodontic purposes
- the teeth should be free of caries and clinical symptoms
- Through thermal tests and radiographic examination absence of any pathology is confirmed.
- Periapical radiographs demonstrating absence of any pathology
- no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds.
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- Absence of any systematic disorder
- No consumption of drugs of any kind
- All patients and their parents need to sign a fully informed consent.
Who cannot join
- If any of the teeth shows caries, restoration, crack or hypocalcification
- presence of any periapical pathosis
- Teeth that seem sensitive to cold, hot, percussion or pressure
- any systematic disorder
- consumption of drugs of any kind.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA
Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.
Read the detailed description
The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation \& dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.
- Conditions
- Dental Pulp Exposure
- Being tested
- Pro Root MTA, Pro Root MTA- single visit, MultiCal, Dycal
- Keywords
- direct pulp capping, MTA, Single visit pulp cap, Multical
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro Root MTADrug
Also called Mineral Trioxide Aggregate
application of MTA in second group and 24 hour interval before restoration
Pro Root MTA- single visitDrug
Also called Mineral Trioxide Aggregate
application of MTA in third group and 15 minute interval before restoration
MultiCalDrug
Also called Hard set calcium hydroxide paste
application of Multical in forth group as a pulp dressing agent
DycalDrug
Also called chemical set calcium hydroxide
application of Dycal in first group as a pulp dressing agent
| Study group | Role | What they receive |
|---|---|---|
| Pro Root MTA- standard method | Experimental | application of MTA in second group and 24 hour interval before restoration Receives: Drug: Pro Root MTA |
| Pro Root MTA- single visit | Experimental | Intervention/Control application of MTA in third group and 15 minute interval before restoration Receives: Drug: Pro Root MTA- single visit |
| MultiCal / LimeLite | Experimental | application of Multical in forth group Receives: Drug: MultiCal |
| Dycal | Active comparator | application of Dycal in first group as a pulp dressing agent Receives: Drug: Dycal |
What is being measured
The primary outcome is the main question the study is designed to answer.
histologic findings - inflammation of the pulp
According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points.
Measured: 6weeks
Secondary outcomes (1)
histologic findings - formation of the dentinal bridge
The specimens will be evaluated in the terms of dentinal bridge formation and its resemblence to natural dentin and also the thickness of the bridge.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJun 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp ExposureStudies 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
- 32 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, Resident, Principal investigator, Fazlyab Mahta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468480
- Sponsor's protocol ID
- p/261/d
- Status last verified
- Nov 2011
- First submitted
- 4 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA
- ClinicalTrials.gov ID
- NCT01468480
- Acronym / sponsor ID
- p/261/d
- Conditions
- Dental Pulp Exposure
- Keywords
- direct pulp capping, MTA, Single visit pulp cap, Multical
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Nov 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.
Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.
Detailed description
The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation \& dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pro Root MTA- standard method | Experimental | Drug: Pro Root MTAapplication of MTA in second group and 24 hour interval before restoration |
| Pro Root MTA- single visit | Experimental | Drug: Pro Root MTA- single visitIntervention/Control application of MTA in third group and 15 minute interval before restoration |
| MultiCal / LimeLite | Experimental | Drug: MultiCalapplication of Multical in forth group |
| Dycal | Active comparator | Drug: Dycalapplication of Dycal in first group as a pulp dressing agent |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients aging from 10 to 16
- Patients who need to extract 4 premolars for orthodontic purposes
- the teeth should be free of caries and clinical symptoms
- Through thermal tests and radiographic examination absence of any pathology is confirmed.
- Periapical radiographs demonstrating absence of any pathology
Key exclusion criteria (5 listed)
- If any of the teeth shows caries, restoration, crack or hypocalcification
- presence of any periapical pathosis
- Teeth that seem sensitive to cold, hot, percussion or pressure
- any systematic disorder
- consumption of drugs of any kind.
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 |
|---|---|---|
| Pro Root MTAAlso: Mineral Trioxide Aggregateapplication of MTA in second group and 24 hour interval before restoration | Drug | Pro Root MTA- standard method |
| Pro Root MTA- single visitAlso: Mineral Trioxide Aggregateapplication of MTA in third group and 15 minute interval before restoration | Drug | Pro Root MTA- single visit |
| MultiCalAlso: Hard set calcium hydroxide pasteapplication of Multical in forth group as a pulp dressing agent | Drug | MultiCal / LimeLite |
| DycalAlso: chemical set calcium hydroxideapplication of Dycal in first group as a pulp dressing agent | Drug | Dycal |
Primary outcome
histologic findings - inflammation of the pulp
Time frame: 6weeks
According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points.
1 secondary outcome
histologic findings - formation of the dentinal bridge
Time frame: 6 weeks
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 9 Nov 2011.
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Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
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Pulpotomy in Hypominerlized Permanent Molars.
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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.
Mahta Fazlyab, Resident principal investigator
Fazlyab Mahta
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 Pro Root MTA, Pro Root MTA- single visit and MultiCal in people with Dental Pulp Exposure, 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 9 inclusion and 5 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 9 Nov 2011. 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?
histologic findings - inflammation of the pulp (time frame: 6weeks). 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 9 Nov 2011.