Irreversible PulpitisNCT01561183
Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis
A study testing Indirect pulp capping (IPC), Direct pulp capping (DPC) and Miniature pulpotomy (MP) in people with Irreversible Pulpitis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Indirect pulp capping (IPC), Direct pulp capping (DPC) and Miniature pulpotomy (MP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteIran
- Study dates
- Mar 2012to Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
- Positive response to EPT or cold test
- patients willing to participate in study
- Healthy subjects; absence of any systematic disorder
- Age ≥ 10 years old
- Both gender
- Written informed consent
Who cannot join
- Moderate or severe periodontitis; pockets >3mm
- None restorable tooth
- Internal or external root resorption
- Root canal calcification
- Non vital pulps
- Analgesic taken within the last 8h
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- Active systemic disease
- Pregnancy or nursing
- History of opioid addiction/abuse
- Temporary residency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.
To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.
Read the detailed description
The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.
- Conditions
- Irreversible Pulpitis
- Being tested
- Indirect pulp capping (IPC), Direct pulp capping (DPC), Miniature pulpotomy (MP), Full pulpotomy (FP)
- Keywords
- Vital pulp therapy, Pulp cap, pulpotomy, calcium enriched mixture, CEM cement, Endodontic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect pulp capping (IPC)Procedure or surgery
Also called Indirect pulp capping
Procedure: IPC
The IPC will be performed as follow:
- Anesthesia
- isolation the tooth
- access to the lesion
- incomplete removal of carious tissue from the cavity walls
- indirect pulp capping with ≈2 mm layer calcium enriched mixture cement
- permanent filling with sandwich technique
Direct pulp capping (DPC)Procedure or surgery
Also called Direct pulp capping
Procedure: DPC
The DPC will be performed as follow:
- Anesthesia
- isolation the tooth
- access to the lesion
- complete removal of carious tissue from the cavity walls result in pulp exposure
- preparation of clot-free pulpal mound
- direct pulp capping with ≈2 mm layer calcium enriched mixture cement
- permanent filling with sandwich technique
Miniature pulpotomy (MP)Procedure or surgery
Also called Miniature pulpotomy
Procedure: MP
The MP will be performed as follow:
- Anesthesia
- isolation the tooth
- access to the lesion
- complete removal of carious tissue from the cavity walls result in pulp exposure
- intentionally removal of pulp horn (≈1 mm)
- preparation of clot-free pulpal mound
- direct pulp capping with ≈2 mm layer calcium enriched mixture cement
- permanent filling with sandwich technique
Full pulpotomy (FP)Procedure or surgery
Also called Full pulpotomy
Procedure: FP
The FP will be performed as follow:
- Anesthesia
- isolation the tooth
- access to the lesion
- complete removal of carious tissue from the cavity walls result in pulp exposure
- pulpotomy
- preparation of clot-free pulpal mound
- direct pulp capping with ≈2 mm layer calcium enriched mixture cement
- permanent filling with sandwich technique
| Study group | Role | What they receive |
|---|---|---|
| Indirect pulp capping (IPC) | Experimental | Indirect pulp capping Receives: Procedure: Indirect pulp capping (IPC) |
| Direct pulp capping (DPC) | Experimental | Direct pulp capping Receives: Procedure: Direct pulp capping (DPC) |
| Miniature pulpotomy (MP) | Experimental | Miniature pulpotomy Receives: Procedure: Miniature pulpotomy (MP) |
| Full pulpotomy (FP) | Experimental | Full pulpotomy Receives: Procedure: Full pulpotomy (FP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographical success rates (%) of each treatment group
The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection.
The outcome of radiographic success is classified by using a modification of the Strindberg criteria.
Measured: 1 year
Secondary outcomes (1)
Patient Assessment of Pain with questionnaire
Pain assessment is carried out using the pain Numerical Rating Scale (NRS) with ratings between 0 to 9. Pain assessment is made up to 7 days. One NRS form is given to each patient to complete.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeed Asgary, Shahid Beheshti University of Medical Sciences
- Investigators
- Mohammad Jafar Eghbal, DDS, MS, Study director, Iran Center For Dental Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561183
- Sponsor's protocol ID
- IKHDC: 01-11-1390
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2012
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Asgary S, Ahmadyar M. Can miniature pulpotomy procedure improve treatment outcomes of direct pulp capping? Med Hypotheses. 2012 Feb;78(2):283-5. doi: 10.1016/j.mehy.2011.11.002. Epub 2011 Dec 1.
PubMed 22137499
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Pulp Therapy for Management of Irreversible Pulpitis in Human Permanent Teeth: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01561183
- Acronym / sponsor ID
- IKHDC: 01-11-1390
- Conditions
- Irreversible Pulpitis
- Keywords
- Vital pulp therapy, Pulp cap, pulpotomy, calcium enriched mixture, CEM cement, Endodontic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Mar 2012 (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.
To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.
Detailed description
The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material [calcium enriched mixture (CEM) cement] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Indirect pulp capping (IPC) | Experimental | Procedure: Indirect pulp capping (IPC)Indirect pulp capping |
| Direct pulp capping (DPC) | Experimental | Procedure: Direct pulp capping (DPC)Direct pulp capping |
| Miniature pulpotomy (MP) | Experimental | Procedure: Miniature pulpotomy (MP)Miniature pulpotomy |
| Full pulpotomy (FP) | Experimental | Procedure: Full pulpotomy (FP)Full pulpotomy |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
- Positive response to EPT or cold test
- patients willing to participate in study
- Healthy subjects; absence of any systematic disorder
- Age ≥ 10 years old
Key exclusion criteria (10 listed)
- Moderate or severe periodontitis; pockets >3mm
- None restorable tooth
- Internal or external root resorption
- Root canal calcification
- Non vital pulps
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 |
|---|---|---|
| Indirect pulp capping (IPC)Also: Indirect pulp cappingProcedure: IPC The IPC will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * incomplete removal of carious tissue from the cavity walls * indirect pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique | Procedure or surgery | Indirect pulp capping (IPC) |
| Direct pulp capping (DPC)Also: Direct pulp cappingProcedure: DPC The DPC will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique | Procedure or surgery | Direct pulp capping (DPC) |
| Miniature pulpotomy (MP)Also: Miniature pulpotomyProcedure: MP The MP will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * intentionally removal of pulp horn (≈1 mm) * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique | Procedure or surgery | Miniature pulpotomy (MP) |
| Full pulpotomy (FP)Also: Full pulpotomyProcedure: FP The FP will be performed as follow: * Anesthesia * isolation the tooth * access to the lesion * complete removal of carious tissue from the cavity walls result in pulp exposure * pulpotomy * preparation of clot-free pulpal mound * direct pulp capping with ≈2 mm layer calcium enriched mixture cement * permanent filling with sandwich technique | Procedure or surgery | Full pulpotomy (FP) |
Primary outcome
Clinical and radiographical success rates (%) of each treatment group
Time frame: 1 year
The outcome of clinical success/failure is determined by subjective symptoms and objective observation of inflammation/infection. The outcome of radiographic success is classified by using a modification of the Strindberg criteria.
1 secondary outcome
Patient Assessment of Pain with questionnaire
Time frame: 6-months
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 28 Apr 2017.
- Background: PubMed 22137499Asgary S, Ahmadyar M. Can miniature pulpotomy procedure improve treatment outcomes of direct pulp capping? Med Hypotheses. 2012 Feb;78(2):283-5. doi: 10.1016/j.mehy.2011.11.002. Epub 2011 Dec 1.
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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.
Mohammad Jafar Eghbal, DDS, MS study director
Iran Center For Dental Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect pulp capping (IPC), Direct pulp capping (DPC) and Miniature pulpotomy (MP) in people with Irreversible Pulpitis, 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 7 inclusion and 10 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 28 Apr 2017. 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.
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?
Clinical and radiographical success rates (%) of each treatment group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01561183, which also lists 1 linked publication.
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 28 Apr 2017.