Dental Pulp NecrosisPhase 2NCT01730287
Effect Of Different Lining Materials in Stepwise Excavation
A Phase 2 study testing Calcium Hydroxide, Mineral Trioxide Aggregate(MTA) and CEM cement in people with Dental Pulp Necrosis, run by Azad University of Medical Sciences at 1 site in Iran.
Trial summary
Deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- Calcium Hydroxide, Mineral Trioxide Aggregate(MTA) and CEM cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- May 2010to May 2013
- Phase
- Phase 2
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal , instantaneous , night pain
Who cannot join
- Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Azad University of Medical Sciences, Dental Branch
Tehran, N/A = Not Applicable, 1517884111
Sepideh Banava, Assist-Prof, 982188882321, sbanava@yahoo.com
Mohammad Safaie Yazdi, Dentist, 00989123614034, mohammad.safaei@yahoo.com
About this study
Official title: Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial
Deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root Canal Therapy (RCT).
Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp Capping (IPC), in this technique only the central infected part of the caries is removed in first visit and the rest of the caries will be lined by a suitable material to suppress the remained cariogenic biomass and seal the cavity. This will help the pulp to defend and survive. After a period, the cavity is re-opened and the rest of the caries which is darker, harder and with less bacteria will be removed and the tooth is restored permanently.The aim of this study was to compare the effect of different lining materials in clinical and radiographical symptoms in stepwise excavation without re-enter after one year.
Read the detailed description
In this randomized clinical trial of 4 lining materials have been applied in deep caries teeth in stepwise excavation. The common material which is applied as a liner over the remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility of this liner over time which could interact with sealing of the cavity in long term. It seems that a material with antibacterial activity, good sealing ability and suitable mechanical properties could cause SE be done efficiently with good prognosis.
MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good antibacterial effect like CH with sealing ability that is proposed to be similar to MTA according to its double sealing property. CEM cement has been suggested as a suitable material in pulp capping of permanent molars with irreversible pulpitis.
- Conditions
- Dental Pulp Necrosis
- Being tested
- Control, Calcium Hydroxide, Mineral Trioxide Aggregate(MTA), CEM cement
- Keywords
- Stepwise Excavation, Pulpal vitality, Deep caries lesions, Clinical symptoms, Radiographic evaluation
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDrug
Also called NO liner applied.
The teeth in this group restored only by filling material,without liner application.
Calcium HydroxideDrug
Also called Calcium Hydroxide paste , Dycal,Dentsply.
Calcium Hydroxide paste applied.
Mineral Trioxide Aggregate(MTA)Drug
Also called MTA, white MTA, ProRoot,Dentsply.
MTA applied .
CEM cementDrug
Also called CEM cement, Yektazist,Iran.
CEM cement applied .
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | No lining applied in group1. Receives: Drug: Control |
| CEM cement | Experimental | CEM cement applied over remained caries in group4. Receives: Drug: CEM cement |
| Mineral Trioxide Aggregate (MTA) | Experimental | MTA applied over remained caries in group3. Receives: Drug: Mineral Trioxide Aggregate(MTA) |
| Calcium Hydroxide | Experimental | Calcium Hydroxide applied over remained caries in group2. Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal Vitality
Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startMay 2010
- Primary completionDec 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sepideh Banava.DDS,MS, Azad University of Medical Sciences
- Investigators
- Sepideh Banava, Assist-Prof, Study chair, Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730287
- Sponsor's protocol ID
- AZadUMS-
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial
- ClinicalTrials.gov ID
- NCT01730287
- Acronym / sponsor ID
- AZadUMS-
- Conditions
- Dental Pulp Necrosis
- Keywords
- Stepwise Excavation, Pulpal vitality, Deep caries lesions, Clinical symptoms, Radiographic evaluation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azad University of Medical SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 21 Nov 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.
Deep carious lesions will encounter the dentist with the challenge of selecting a treatment method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional restorative treatments suggest complete removal of the caries in one visit which could cause pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root Canal Therapy (RCT).
Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp Capping (IPC), in this technique only the central infected part of the caries is removed in first visit and the rest of the caries will be lined by a suitable material to suppress the remained cariogenic biomass and seal the cavity. This will help the pulp to defend and survive. After a period, the cavity is re-opened and the rest of the caries which is darker, harder and with less bacteria will be removed and the tooth is restored permanently.The aim of this study was to compare the effect of different lining materials in clinical and radiographical symptoms in stepwise excavation without re-enter after one year.
Detailed description
In this randomized clinical trial of 4 lining materials have been applied in deep caries teeth in stepwise excavation. The common material which is applied as a liner over the remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility of this liner over time which could interact with sealing of the cavity in long term. It seems that a material with antibacterial activity, good sealing ability and suitable mechanical properties could cause SE be done efficiently with good prognosis.
MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good antibacterial effect like CH with sealing ability that is proposed to be similar to MTA according to its double sealing property. CEM cement has been suggested as a suitable material in pulp capping of permanent molars with irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: ControlNo lining applied in group1. |
| CEM cement | Experimental | Drug: CEM cementCEM cement applied over remained caries in group4. |
| Mineral Trioxide Aggregate (MTA) | Experimental | Drug: Mineral Trioxide Aggregate(MTA)MTA applied over remained caries in group3. |
| Calcium Hydroxide | Experimental | Drug: Calcium HydroxideCalcium Hydroxide applied over remained caries in group2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal , instantaneous , night pain
Key exclusion criteria (1 listed)
- Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening
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 |
|---|---|---|
| ControlAlso: NO liner applied.The teeth in this group restored only by filling material,without liner application. | Drug | Control |
| Calcium HydroxideAlso: Calcium Hydroxide paste , Dycal,Dentsply.Calcium Hydroxide paste applied. | Drug | Calcium Hydroxide |
| Mineral Trioxide Aggregate(MTA)Also: MTA, white MTA, ProRoot,Dentsply.MTA applied . | Drug | Mineral Trioxide Aggregate (MTA) |
| CEM cementAlso: CEM cement, Yektazist,Iran.CEM cement applied . | Drug | CEM cement |
Primary outcome
Pulpal Vitality
Time frame: One year
Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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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.
Sepideh Banava, Assist-Prof study chair
Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium Hydroxide, Mineral Trioxide Aggregate(MTA) and CEM cement in people with Dental Pulp Necrosis, run by Azad 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 1 inclusion and 1 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 21 Nov 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 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.
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 Sepideh Banava, Assist-prof (982188882321, sbanava@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulpal Vitality (time frame: 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 21 Nov 2012.