Pulpitis - IrreversiblePhase 4GCPNCT05853185
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
A Phase 4 study testing Pro Root MTA® and EBRRM® in people with Pulpitis - Irreversible, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial summary
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 10 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Pro Root MTA® and EBRRM®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Oct 2021to 30 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with diagnosis of irreversible pulpitis without apical periodontitis
- Either gender
- Lower Age 10 Years - Upper Age 40 Years
Who cannot join
- Teeth displaying indications of resorption.
- Teeth that have not fully developed, characterized by open apices.
- Canals that are calcified or obstructed.
- Perforations that were caused by the dentist.
- Fractures in the root
- Teeth that cannot be restored
Show all 10Show fewer
- • Teeth that are unable to withstand frigid temperatures, have a sinus infection, or have swelling around them.
- There has been no pulp exposure despite the removal of carious lesion.
- Ten minutes after a pulpotomy, hemorrhage could not be stopped.
- Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat University of Medical and Health Sciences
Jāmshoro, Sindh
About this study
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.
Read the detailed description
The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Pro Root MTA®, EBRRM®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro Root MTA®Drug
Patients in this group will receive the pulpotomy with Pro Root MTA®.
EBRRM®Drug
Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
| Study group | Role | What they receive |
|---|---|---|
| Pro Root MTA® | Experimental | Patients in this group will receive the pulpotomy with Pro Root MTA®. Receives: Drug: Pro Root MTA® |
| EBRRM® | Active comparator | Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. Receives: Drug: EBRRM® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at 6 Months
Number of participants with clinical success based on following criteria
- No complaints of pain or discomfort outside of the initial two days following therapy.
- The tooth shows no signs of pain upon palpation or percussion.
- A probing pocket depth of less than 4 mm and 1 mm are indicative of normal movement.
- No inflammation or sinus tract can be seen in the soft tissues around the teeth.
Measured: 6 Months
Secondary outcomes (1)
Radiographic Success
Number of participants with clinical success based on absence of Root resorption, furcal pathosis, or fresh periapical pathosis on the radiograph
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 posted10 May 2023
- Study start12 Oct 2021
- Primary completion30 May 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulpitis - IrreversibleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarang Suresh, Liaquat University of Medical & Health Sciences
- Investigators
- Sarang Suresh, Principal investigator, Liaquat University of Medical and Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853185
- Sponsor's protocol ID
- LUMHS/REC/-93
- Acronym
- GCP
- Status last verified
- Aug 2023
- First submitted
- 25 Mar 2023
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
- ClinicalTrials.gov ID
- NCT05853185
- Acronym / sponsor ID
- GCP / LUMHS/REC/-93
- Conditions
- Pulpitis - Irreversible
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Posted 24 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.
Detailed description
The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pro Root MTA® | Experimental | Drug: Pro Root MTA®Patients in this group will receive the pulpotomy with Pro Root MTA®. |
| EBRRM® | Active comparator | Drug: EBRRM®Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®. |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of irreversible pulpitis without apical periodontitis
- Either gender
- Lower Age 10 Years - Upper Age 40 Years
Key exclusion criteria (10 listed)
- Teeth displaying indications of resorption.
- Teeth that have not fully developed, characterized by open apices.
- Canals that are calcified or obstructed.
- Perforations that were caused by the dentist.
- Fractures in the root
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 MTA®Patients in this group will receive the pulpotomy with Pro Root MTA®. | Drug | Pro Root MTA® |
| EBRRM®Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®. | Drug | EBRRM® |
Primary outcome
Clinical Success at 6 Months
Time frame: 6 Months
Number of participants with clinical success based on following criteria * No complaints of pain or discomfort outside of the initial two days following therapy. * The tooth shows no signs of pain upon palpation or percussion. * A probing pocket depth of less than 4 mm and 1 mm are indicative of normal movement. * No inflammation or sinus tract can be seen in the soft tissues around the teeth.
1 secondary outcome
Radiographic Success
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sarang Suresh principal investigator
Liaquat University of Medical and Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pro Root MTA® and EBRRM® in people with Pulpitis - Irreversible, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
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 3 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 24 Aug 2023. 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Success at 6 Months (time frame: 6 Months). 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 24 Aug 2023.