Irreversible Pulpitis With Apical PeriodontitisNCT07768852
Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis
A study testing Full pulpotomy in people with Irreversible Pulpitis With Apical Periodontitis, run by King Abdullah University Hospital.
Trial summary
This study will evaluate whether full pulpotomy can successfully treat mature permanent teeth with irreversible pulp inflammation and a periapical lesion. Full pulpotomy involves removing the inflamed pulp tissue from the crown of the tooth while preserving the healthy tissue inside the roots. Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis With Apical Periodontitis
- What is being tested?
- Full pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2026to Oct 2030
- 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 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Non -contributory medical history (SAI, II).
- Posterior permanent tooth (premolar, molar).
- Age range 8-30 years
- Deep caries extending into the inner quarter of dentin or exposing the pulp on the periapical radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of symptomatic/asymptomatic irreversible pulpitis based on the symptoms, radiographic findings and results of cold testing
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- Periapical radiograph demonstrates the presence of periapical lesion.
Who cannot join
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- Evidence of necrotic tissue in one or all canals.
- Profuse pulpal bleeding and inability to achieve hemostasis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.
This study will evaluate whether full pulpotomy can successfully treat mature permanent teeth with irreversible pulp inflammation and a periapical lesion. Full pulpotomy involves removing the inflamed pulp tissue from the crown of the tooth while preserving the healthy tissue inside the roots. The study will assess pain relief, patient satisfaction, and clinical and radiographic healing over time, including healing of the periapical lesion using dental X-rays and limited-field CBCT imaging. The findings may help determine whether full pulpotomy can provide a less invasive alternative to root canal treatment for selected teeth with periapical lesions.
Read the detailed description
This is a single-arm, prospective clinical study evaluating the effectiveness of full pulpotomy in mature permanent posterior teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis and associated periapical radiolucency. The study will be conducted at the endodontic postgraduate, with a minimum target of 30 teeth in 30 patients recruited consecutively during the study period.
Eligible teeth will undergo clinical and radiographic assessment, including cold sensibility testing, percussion, palpation, periodontal assessment, and periapical radiography. Following local anesthesia and rubber dam isolation, caries will be completely removed and full pulpotomy will be performed to the level of the root canal orifices. The vitality of the remaining pulp tissue will be assessed clinically. Hemostasis will initially be attempted using sodium hypochlorite-moistened cotton pellets. A 980-nm diode laser will then be applied to the pulp tissue to assist hemostasis. Following adequate hemostasis, a calcium silicate-based pulp capping material will be placed over the pulp stumps, followed by a resin-modified glass ionomer liner and definitive resin composite restoration.
Teeth found to have complete pulpal necrosis or in which adequate hemostasis cannot be achieved will not proceed with the pulpotomy protocol and will receive appropriate endodontic treatment according to the clinical findings.
Clinical and radiographic follow-up will be performed at 6 and 12 months, with additional follow-up planned at 24 and 36 months. Periapical radiographs will be obtained during follow-up, and limited-field CBCT will be obtained immediately after treatment and at 12 months to assess changes in the periapical lesion. Treatment success will be determined based on the absence of clinical signs and symptoms and evidence of resolution or reduction of the periapical lesion. Radiographic healing will be assessed by comparing follow-up images with baseline postoperative images.
Patient-reported outcomes will include postoperative pain, analgesic intake, oral health-related quality of life, and patient satisfaction. Pain will be assessed before treatment and at 3 days and 1 week after treatment. Oral health-related quality of life and patient satisfaction will be assessed before treatment, at 1 week, and at 12 months.
The study will provide clinical and radiographic evidence regarding the feasibility and outcome of full pulpotomy in selected permanent teeth with irreversible pulpitis and periapical radiolucency. It will also assess patient-reported outcomes associated with this treatment approach and explore whether full pulpotomy may represent a less invasive alternative to conventional root canal treatment in appropriately selected cases.
- Being tested
- Full pulpotomy
- Keywords
- Pulpitis, Periapical lesion, Pulpotomy, Laser
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full pulpotomyProcedure or surgery
Also called Cervical pulpotomy, Coronal pulpotomy
Full pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping. The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. | Experimental | Participants will receive full pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. Treatment outcomes will be evaluated clinically and radiographically during follow-up. Receives: Procedure: Full pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of pulpotomy
Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.
Measured: 6 and 12 months
Secondary outcomes (1)
Postoperative pain
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain.
Measured: 3 and 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start7 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis With Apical PeriodontitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, prospective clinical study. All eligible participants will receive the same full pulpotomy treatment protocol, including diode-laser-assisted hemostasis and calcium silicate-based pulp capping. Treatment outcomes will be evaluated clinically and radiographically during follow-up. There is no randomization or concurrent control group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessrin Taha, King Abdullah University Hospital
- Investigators
- Nessrin Taha, DClinDent, PhD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768852
- Sponsor's protocol ID
- 550/226
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared publicly due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the Principal Investigator following publication of the study results, in accordance with university policies and applicable ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.
- ClinicalTrials.gov ID
- NCT07768852
- Acronym / sponsor ID
- 550/226
- Keywords
- Pulpitis, Periapical lesion, Pulpotomy, Laser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 17 Aug 2026 (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 study will evaluate whether full pulpotomy can successfully treat mature permanent teeth with irreversible pulp inflammation and a periapical lesion. Full pulpotomy involves removing the inflamed pulp tissue from the crown of the tooth while preserving the healthy tissue inside the roots. The study will assess pain relief, patient satisfaction, and clinical and radiographic healing over time, including healing of the periapical lesion using dental X-rays and limited-field CBCT imaging. The findings may help determine whether full pulpotomy can provide a less invasive alternative to root canal treatment for selected teeth with periapical lesions.
Detailed description
This is a single-arm, prospective clinical study evaluating the effectiveness of full pulpotomy in mature permanent posterior teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis and associated periapical radiolucency. The study will be conducted at the endodontic postgraduate, with a minimum target of 30 teeth in 30 patients recruited consecutively during the study period.
Eligible teeth will undergo clinical and radiographic assessment, including cold sensibility testing, percussion, palpation, periodontal assessment, and periapical radiography. Following local anesthesia and rubber dam isolation, caries will be completely removed and full pulpotomy will be performed to the level of the root canal orifices. The vitality of the remaining pulp tissue will be assessed clinically. Hemostasis will initially be attempted using sodium hypochlorite-moistened cotton pellets. A 980-nm diode laser will then be applied to the pulp tissue to assist hemostasis. Following adequate hemostasis, a calcium silicate-based pulp capping material will be placed over the pulp stumps, followed by a resin-modified glass ionomer liner and definitive resin composite restoration.
Teeth found to have complete pulpal necrosis or in which adequate hemostasis cannot be achieved will not proceed with the pulpotomy protocol and will receive appropriate endodontic treatment according to the clinical findings.
Clinical and radiographic follow-up will be performed at 6 and 12 months, with additional follow-up planned at 24 and 36 months. Periapical radiographs will be obtained during follow-up, and limited-field CBCT will be obtained immediately after treatment and at 12 months to assess changes in the periapical lesion. Treatment success will be determined based on the absence of clinical signs and symptoms and evidence of resolution or reduction of the periapical lesion. Radiographic healing will be assessed by comparing follow-up images with baseline postoperative images.
Patient-reported outcomes will include postoperative pain, analgesic intake, oral health-related quality of life, and patient satisfaction. Pain will be assessed before treatment and at 3 days and 1 week after treatment. Oral health-related quality of life and patient satisfaction will be assessed before treatment, at 1 week, and at 12 months.
The study will provide clinical and radiographic evidence regarding the feasibility and outcome of full pulpotomy in selected permanent teeth with irreversible pulpitis and periapical radiolucency. It will also assess patient-reported outcomes associated with this treatment approach and explore whether full pulpotomy may represent a less invasive alternative to conventional root canal treatment in appropriately selected cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective clinical study. All eligible participants will receive the same full pulpotomy treatment protocol, including diode-laser-assisted hemostasis and calcium silicate-based pulp capping. Treatment outcomes will be evaluated clinically and radiographically during follow-up. There is no randomization or concurrent control group.
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. | Experimental | Procedure: Full pulpotomyParticipants will receive full pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. Treatment outcomes will be evaluated clinically and radiographically during follow-up. |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- • Non -contributory medical history (SAI, II).
Key exclusion criteria (4 listed)
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- Evidence of necrotic tissue in one or all canals.
- Profuse pulpal bleeding and inability to achieve hemostasis.
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 |
|---|---|---|
| Full pulpotomyAlso: Cervical pulpotomy, Coronal pulpotomyFull pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping. The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment. | Procedure or surgery | Pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis. |
Primary outcome
Success of pulpotomy
Time frame: 6 and 12 months
Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.
1 secondary outcome
Postoperative pain
Time frame: 3 and 7 days after treatment
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 Aug 2026.
- A review study published by main investigator on managemnt of teeth with carious pulp exposure with variable diagnosis and periapical status.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared publicly due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the Principal Investigator following publication of the study results, in accordance with university policies and applicable ethical requirements.
Related trials for Irreversible Pulpitis With Apical Periodontitis
Not yet recruitingObservational study
Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis
Symptomatic Irreversible Pulpitis With Apical Peridontitis
Not yet recruiting
Assessment of Post-Operative Pain After Using Cryotherapy and Dexamethasone
Post Operative Pain
Not yet recruiting
Effect of Two Different Cryotherapy Irrigation Protocols on Postoperative Endodontic Pain
Cryotherapy
Active, not recruiting
Vital Pulp Therapy Versus Root Canal Treatment for Irreversible Pulpitis With Incipient Apical Periodontitis Diagnosed Using Artificial Intelligence This Keeps: the Main Intervention (Vital Pulp Therapy) the Comparison (Root Canal Treatment) the Condition (Irreversible Pulpitis With Incipient Apic
Symptomatic Irreversible Pulpitis
Not yet recruitingPhase 2
The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis.
Postoperative Pain
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.
Nessrin Taha, DClinDent, PhD study chair
Jordan University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Full pulpotomy in people with Irreversible Pulpitis With Apical Periodontitis, run by King Abdullah University Hospital.
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 8 inclusion and 4 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Nessrin Taha, DclinDent (Endo), PhD (+962776566110, n.taha@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of pulpotomy (time frame: 6 and 12 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 17 Aug 2026.