Symptomatic Irreversible PulpitisNCT07549620
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
A study testing Vital Pulp Therapy and Root Canal Treatment in people with Symptomatic Irreversible Pulpitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study evaluates postoperative pain and treatment outcomes following vital pulp therapy and root canal treatment in patients with symptomatic teeth. Participants will receive either vital pulp therapy or standard root canal treatment, and pain will be measured using standardized pain scores at different time… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Vital Pulp Therapy and Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to 8 Apr 2027
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mandibular molars with with deep caries exposing the pulp and preoperative symptoms, such as spontaneous or referred pain.
- Mandibular molars lacking noticeable radiolucency in the furcation or periapical areas. (Periapical Index scores of 1 and 2)
- Patients aged 18-40 years with teeth diagnosed with acute irreversible pulpitis and symptomatic apical periodontitis.
- Patients willing to provide written informed consent for participation in the study.
- Restorable teeth and adequate periodontal support.
Who cannot join
- Teeth with prior endodontic treatment or history of trauma.
- Teeth with internal or external resorption, prominent radiolucency at the periapical regions or furcation. (Periapical Index score of 3, 4 and 5)
- Teeth that are not responsive to vitality tests.
- Pregnant or lactating women due to potential risks associated with radiographic exposure.
- Patients with systemic diseases (e.g., uncontrolled diabetes, immunosuppression) that may affect healing.
- Teeth with advanced periodontal disease (e.g., mobility grade II or III, furcation involvement).
- Patients unable to attend follow-up appointments for up to one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vital Pulp Therapy in Acute Irreversible Pulpitis With Incipient Apical Periodontitis Cases Diagnosed by the Aid of Artificial Intelligence: A Randomized Controlled Clinical Trial
This study evaluates postoperative pain and treatment outcomes following vital pulp therapy and root canal treatment in patients with symptomatic teeth. Participants will receive either vital pulp therapy or standard root canal treatment, and pain will be measured using standardized pain scores at different time intervals after treatment.
The primary outcome is postoperative pain intensity in the early healing period. Secondary outcomes include long-term clinical and radiographic success at 6 months and 1 year.
Read more
Radiographic outcomes will be assessed using artificial intelligence (AI)-assisted analysis to improve evaluation of healing and treatment success.
The study aims to compare pain progression and long-term outcomes between the two treatment approaches.
Read the detailed description
This study is designed to evaluate postoperative pain and treatment outcomes following endodontic procedures, including both root canal treatment (RCT) and vital pulp therapy (VPT), in patients presenting with symptomatic pulpal conditions.
Participants will receive treatment according to clinical indication, either RCT or VPT. Postoperative pain will be assessed using standardized pain scoring systems at defined time intervals following treatment to evaluate short-term patient discomfort and recovery patterns.
The primary outcome measure is postoperative pain intensity following endodontic intervention during the early healing period.
Secondary outcomes include the long-term clinical and radiographic success of treated teeth, evaluated at 6 months and 1 year post-treatment.
Radiographic evaluation will be performed using standardized periapical radiographs, and outcomes will be assessed using artificial intelligence (AI)-assisted image analysis to support objective evaluation of periapical healing and treatment success.
The study aims to compare postoperative pain and treatment outcomes between RCT and vital pulp therapy, and to integrate AI-based radiographic assessment to improve the accuracy and consistency of outcome evaluation in endodontic treatment.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Vital Pulp Therapy, Root Canal Treatment
- Keywords
- Vital pulp therapy, Root canal treatment, Endodontic treatment, Postoperative pain, Pain assessment, Symptomatic teeth, Pulpitis, AI radiographic analysis, Artificial intelligence
- Medical subject headings
- Pain, Postoperative, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Pulp TherapyProcedure or surgery
Vital pulp therapy will be performed on symptomatic teeth according to clinical indication to preserve pulp vitality. Postoperative pain will be assessed using standardized pain scoring methods, and radiographic healing will be evaluated using AI-assisted analysis.
Root Canal TreatmentProcedure or surgery
Conventional root canal treatment will be performed on symptomatic teeth according to standard clinical protocols. Postoperative pain will be assessed using standardized pain scoring methods, and radiographic healing will be evaluated using AI-assisted analysis.
| Study group | Role | What they receive |
|---|---|---|
| Vital Pulp Therapy | Active comparator | Participants receive vital pulp therapy for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up. Receives: Procedure: Vital Pulp Therapy |
| Root Canal Treatment | Active comparator | Participants receive conventional root canal treatment for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up. Receives: Procedure: Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Postoperative pain assessment using modified Visual Analogue Scale. Postoperative pain assessment after 24 hours and 1 week.
Measured: 1 Week
Secondary outcomes (1)
Clinical and AI- assisted Radiographic long term success rate of vital pulp therapy and Root Canal Treatment
Evaluations at 6 and 12 months for clinical signs and symptoms (presence or absence of pain or swelling) and AI- assisted radiographs (presence or absence of lesion).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start15 Nov 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel study groups based on the treatment modality: vital pulp therapy or conventional root canal treatment. Each participant will receive only one intervention and will be followed prospectively to evaluate postoperative pain and treatment outcomes. The two groups will be assessed independently over the study period to compare clinical, radiographic, and patient-reported outcomes.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abeer Elgendy, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549620
- Sponsor's protocol ID
- FDASU-Rec ID032513
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a single-center academic clinical study, and data sharing is not required by the study protocol or ethics approval. All published results will be reported in aggregate form to ensure participant confidentiality and data protection.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vital Pulp Therapy in Acute Irreversible Pulpitis With Incipient Apical Periodontitis Cases Diagnosed by the Aid of Artificial Intelligence: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07549620
- Acronym / sponsor ID
- FDASU-Rec ID032513
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Vital pulp therapy, Root canal treatment, Endodontic treatment, Postoperative pain, Pain assessment, Symptomatic teeth, Pulpitis, AI radiographic analysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2027 (estimated)
- First posted
- 24 Apr 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 evaluates postoperative pain and treatment outcomes following vital pulp therapy and root canal treatment in patients with symptomatic teeth. Participants will receive either vital pulp therapy or standard root canal treatment, and pain will be measured using standardized pain scores at different time intervals after treatment.
The primary outcome is postoperative pain intensity in the early healing period. Secondary outcomes include long-term clinical and radiographic success at 6 months and 1 year.
Radiographic outcomes will be assessed using artificial intelligence (AI)-assisted analysis to improve evaluation of healing and treatment success.
The study aims to compare pain progression and long-term outcomes between the two treatment approaches.
Detailed description
This study is designed to evaluate postoperative pain and treatment outcomes following endodontic procedures, including both root canal treatment (RCT) and vital pulp therapy (VPT), in patients presenting with symptomatic pulpal conditions.
Participants will receive treatment according to clinical indication, either RCT or VPT. Postoperative pain will be assessed using standardized pain scoring systems at defined time intervals following treatment to evaluate short-term patient discomfort and recovery patterns.
The primary outcome measure is postoperative pain intensity following endodontic intervention during the early healing period.
Secondary outcomes include the long-term clinical and radiographic success of treated teeth, evaluated at 6 months and 1 year post-treatment.
Radiographic evaluation will be performed using standardized periapical radiographs, and outcomes will be assessed using artificial intelligence (AI)-assisted image analysis to support objective evaluation of periapical healing and treatment success.
The study aims to compare postoperative pain and treatment outcomes between RCT and vital pulp therapy, and to integrate AI-based radiographic assessment to improve the accuracy and consistency of outcome evaluation in endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel study groups based on the treatment modality: vital pulp therapy or conventional root canal treatment. Each participant will receive only one intervention and will be followed prospectively to evaluate postoperative pain and treatment outcomes. The two groups will be assessed independently over the study period to compare clinical, radiographic, and patient-reported outcomes.
| Arm | Type | Receives |
|---|---|---|
| Vital Pulp Therapy | Active comparator | Procedure: Vital Pulp TherapyParticipants receive vital pulp therapy for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up. |
| Root Canal Treatment | Active comparator | Procedure: Root Canal TreatmentParticipants receive conventional root canal treatment for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mandibular molars with with deep caries exposing the pulp and preoperative symptoms, such as spontaneous or referred pain.
- Mandibular molars lacking noticeable radiolucency in the furcation or periapical areas. (Periapical Index scores of 1 and 2)
- Patients aged 18-40 years with teeth diagnosed with acute irreversible pulpitis and symptomatic apical periodontitis.
- Patients willing to provide written informed consent for participation in the study.
- Restorable teeth and adequate periodontal support.
Key exclusion criteria (7 listed)
- Teeth with prior endodontic treatment or history of trauma.
- Teeth with internal or external resorption, prominent radiolucency at the periapical regions or furcation. (Periapical Index score of 3, 4 and 5)
- Teeth that are not responsive to vitality tests.
- Pregnant or lactating women due to potential risks associated with radiographic exposure.
- Patients with systemic diseases (e.g., uncontrolled diabetes, immunosuppression) that may affect healing.
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 |
|---|---|---|
| Vital Pulp TherapyVital pulp therapy will be performed on symptomatic teeth according to clinical indication to preserve pulp vitality. Postoperative pain will be assessed using standardized pain scoring methods, and radiographic healing will be evaluated using AI-assisted analysis. | Procedure or surgery | Vital Pulp Therapy |
| Root Canal TreatmentConventional root canal treatment will be performed on symptomatic teeth according to standard clinical protocols. Postoperative pain will be assessed using standardized pain scoring methods, and radiographic healing will be evaluated using AI-assisted analysis. | Procedure or surgery | Root Canal Treatment |
Primary outcome
Pain Score
Time frame: 1 Week
Postoperative pain assessment using modified Visual Analogue Scale. Postoperative pain assessment after 24 hours and 1 week.
1 secondary outcome
Clinical and AI- assisted Radiographic long term success rate of vital pulp therapy and Root Canal Treatment
Time frame: 1 Year
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 24 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a single-center academic clinical study, and data sharing is not required by the study protocol or ethics approval. All published results will be reported in aggregate form to ensure participant confidentiality and data protection.
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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.
Abeer Elgendy, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital Pulp Therapy and Root Canal Treatment in people with Symptomatic Irreversible Pulpitis, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 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 Egypt. 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?
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?
Pain Score (time frame: 1 Week). 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 Apr 2026.