Irreversible PulpitisNCT04922229
Comparative Effectiveness in the Management of Irreversible Pulpitis
A study testing RCT and Pulpotomy in people with Irreversible Pulpitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of… Read more about this study
- Who is it for?
- Ages 12 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- RCT and Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia >30 seconds), and normal apical tissues.
- Tooth is responsive to cold and electrical pulp testing.
- Patients aged ≥12 years for first molars and ≥16 years for second molars.
Who cannot join
- Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
- Teeth that are badly broken down and/or are not restorable.
- Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side.
- Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.
- Radiographic evidence of PDL space wider than three times normal width
- Clinical evidence of swelling or sinus tract
Show all 17Show fewer
- Periodontal pocket probing depth ≥5 mm in any site around the tooth.
- Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥ 5 mm.
- History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months.
- Use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin.
- Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications.
- Patients who require IV sedation or general anesthesia for their dental treatment.
- Teeth with full coverage crowns.
- Teeth undergoing active orthodontic movement.
- Teeth that require elective RCTx to place a post for restorative purposes.
- Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls.
- Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
School of Dentistry, University of Alabama at Birmingham
Birmingham, Alabama, 35233
Sheila Turner, (205) 934-5045, jordan@uab.edu
Ashraf Fouad, DDS
About this study
This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.
Read the detailed description
In this study, patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.
- Conditions
- Irreversible Pulpitis
- Being tested
- RCT, Pulpotomy
- Keywords
- Pulpotomy, Vital Pulp Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCTProcedure or surgery
Also called Endodontic therapy
This is the standard of care for this diagnosis
PulpotomyProcedure or surgery
Also called Therapeutic pulpotomy
For cases with normal apical tissues, pulpotomy using tricalcium silicates has been shown to have high clinical success. Either partial or complete pulpotomy will be performed depending on the size of pulp exposure.
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment (RCT) | Active comparator | For cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols Receives: Procedure: RCT |
| Pulpotomy | Experimental | Pulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here. Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a successful outcome of pulpotomy versus RCT
A composite of clinical and radiographic findings and incidence of follow up procedures
Measured: From baseline through 2 years
Secondary outcomes (2)
Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy
Neurosensory measurements of preoperative signs and symptoms will be measured and correlated with the outcome of pulpotomy
Measured: From baseline to two years
Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy
Protein analysis at the time of treatment will be correlated with the outcome of pulpotomy
Measured: From baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2027 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Fouad, University of Alabama at Birmingham
- Investigators
- Ashraf Fouad, DDS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922229
- Sponsor's protocol ID
- IRB-300001234
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness in the Management of Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT04922229
- Acronym / sponsor ID
- IRB-300001234
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpotomy, Vital Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 10 Jun 2021 (actual)
- 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.
This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.
Detailed description
In this study, patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment (RCT) | Active comparator | Procedure: RCTFor cases with this diagnosis RCT is the standard of care and will be done according to clinically approved protocols |
| Pulpotomy | Experimental | Procedure: PulpotomyPulpotomy with tricalcium silicates has shown high clinical success in these cases. However, it is not known how this success compares to RCT under similar conditions and with an intent-to-treat study design, which will be employed here. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia >30 seconds), and normal apical tissues.
- Tooth is responsive to cold and electrical pulp testing.
- Patients aged ≥12 years for first molars and ≥16 years for second molars.
Key exclusion criteria (17 listed)
- Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
- Teeth that are badly broken down and/or are not restorable.
- Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side.
- Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.
- Radiographic evidence of PDL space wider than three times normal width
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 |
|---|---|---|
| RCTAlso: Endodontic therapyThis is the standard of care for this diagnosis | Procedure or surgery | Root canal treatment (RCT) |
| PulpotomyAlso: Therapeutic pulpotomyFor cases with normal apical tissues, pulpotomy using tricalcium silicates has been shown to have high clinical success. Either partial or complete pulpotomy will be performed depending on the size of pulp exposure. | Procedure or surgery | Pulpotomy |
Primary outcome
Percentage of patients with a successful outcome of pulpotomy versus RCT
Time frame: From baseline through 2 years
A composite of clinical and radiographic findings and incidence of follow up procedures
2 secondary outcomes
Determine prognostic validity of preoperative hyperalgesia in determining the outcome of pulpotomy
Time frame: From baseline to two years
Determine prognostic validity of a set of pulpal inflammatory proteins in determining the outcome of pulpotomy
Time frame: From baseline to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. To be determined
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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.
Ashraf Fouad, DDS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RCT and Pulpotomy in people with Irreversible Pulpitis, run by University of Alabama at Birmingham at 1 site in United States.
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 17 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: opening soon, as of the sponsor's last update on 17 Feb 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheila Turner, DDS ((205) 934-5045, jordan@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a successful outcome of pulpotomy versus RCT (time frame: From baseline through 2 years). 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 17 Feb 2026.