Irreversible Pulpitis (Toothache)NCT07287709
Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis
A study testing Diode laser and Sodium Hypochlorite Solution in people with Irreversible Pulpitis (Toothache), run by Rana Hegaz at 1 site in Egypt.
Trial summary
this clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Irreversible Pulpitis (Toothache)
- What is being tested?
- Diode laser and Sodium Hypochlorite Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2025to May 2026
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Permanent molar teeth with symptomatic irreversible pulpitis.
- The patient should be ≥ 16 to 50 years old.
- Teeth should give positive response to cold testing and clinical diagnosis of SIP with or without periapical rarefaction.
- Teeth will be selected only if they are restorable.
- Patient medically healthy and free from systemic diseases. ASA I, II.
- patients who agreed to participate in the study to attend the control visits.
- Teeth with periapical index score (PAI) 1 and 2 will be selected
Who cannot join
- Teeth with necrotic pulp, resorption or subgingival caries.
- Teeth with open apices.
- Medically compromised patients.
- Pregnant patients.
- Patients with uncontrollable bleeding from the radicular pulp.
- Patients with (PAI) score 3-5 will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Alexandria, 21527
Rana Mahmoud Hegazi, Assistant lecturer, 01094428209, ranahegazi1991@gmail.com
About this study
Official title: Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
this clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI).
Read the detailed description
Sixty human permanent molar teeth having irreversible pulpitis will be selected. Teeth will be randomly divided into 3 groups according to the type of pulpotomy; Group A: Photobiomodulation (PBM) pulpotomy, Group B: photocoagulation pulpotomy and Group C: Conventional pulpotomy which will serve as control. All 3 groups will be capped with bioceramic putty material. Post operative pain will be assessed at 24, 48 and 72 hours then after one week using numerical rating scale (NRS). Clinical and radiographic assessment using periapical radiograph of the healing progress will be done simultaneously during the follow up at one, three, six and 12 months intervals. CBCT will be done immediate postoperative and at the end of the follow up period to assess the dentin bridge formation and for automated segmentation to assess the radicular pulp volume changes.
- Conditions
- Irreversible Pulpitis (Toothache)
- Being tested
- Diode laser, Sodium Hypochlorite Solution
- Keywords
- Photobiomodulation,, photocoagulation,, pulpotomy,, segmentation,, irreversible pulpitis, artificial intelligence, bioceramic putty
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue
Sodium Hypochlorite SolutionOther
A disinfecting agent used in conventional pulpotomy procedures
| Study group | Role | What they receive |
|---|---|---|
| Group A Photo-biomodulation pulpotomy with Bioceramic putty | Experimental | Not described Receives: Device: Diode laser |
| Group B photocoagulation pulpotomy with Bioceramic putty | Experimental | Not described Receives: Device: Diode laser |
| Group C(Control) Conventional pulpotomy with Bioceramic putty | Active comparator | Not described Receives: Other: Sodium Hypochlorite Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of healing progress
evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question.
-
Measured: one year
Radiographic assessment of the dentin bridge formation
evaluating the dentin bridge formation using periapical radiographs and CBCT
Measured: one year
Automated segmentation of the radicular pulp space
this will be done using CBCT imaging
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 posted17 Dec 2025
- Study start7 Nov 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Pulpitis (Toothache)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rana Hegaz
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Rana Hegaz, Alexandria University
- Investigators
- Rania Noaman ELbackly, Professor, Principal investigator, Endodontics, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287709
- Sponsor's protocol ID
- 9258137
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07287709
- Acronym / sponsor ID
- 9258137
- Conditions
- Irreversible Pulpitis (Toothache)
- Keywords
- Photobiomodulation,, photocoagulation,, pulpotomy,, segmentation,, irreversible pulpitis, artificial intelligence, bioceramic putty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rana HegazUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 17 Dec 2025 (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 clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI).
Detailed description
Sixty human permanent molar teeth having irreversible pulpitis will be selected. Teeth will be randomly divided into 3 groups according to the type of pulpotomy; Group A: Photobiomodulation (PBM) pulpotomy, Group B: photocoagulation pulpotomy and Group C: Conventional pulpotomy which will serve as control. All 3 groups will be capped with bioceramic putty material. Post operative pain will be assessed at 24, 48 and 72 hours then after one week using numerical rating scale (NRS). Clinical and radiographic assessment using periapical radiograph of the healing progress will be done simultaneously during the follow up at one, three, six and 12 months intervals. CBCT will be done immediate postoperative and at the end of the follow up period to assess the dentin bridge formation and for automated segmentation to assess the radicular pulp volume changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A Photo-biomodulation pulpotomy with Bioceramic putty | Experimental | Device: Diode laser |
| Group B photocoagulation pulpotomy with Bioceramic putty | Experimental | Device: Diode laser |
| Group C(Control) Conventional pulpotomy with Bioceramic putty | Active comparator | Other: Sodium Hypochlorite Solution |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Permanent molar teeth with symptomatic irreversible pulpitis.
- The patient should be ≥ 16 to 50 years old.
- Teeth should give positive response to cold testing and clinical diagnosis of SIP with or without periapical rarefaction.
- Teeth will be selected only if they are restorable.
- Patient medically healthy and free from systemic diseases. ASA I, II.
Key exclusion criteria (6 listed)
- Teeth with necrotic pulp, resorption or subgingival caries.
- Teeth with open apices.
- Medically compromised patients.
- Pregnant patients.
- Patients with uncontrollable bleeding from the radicular pulp.
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 |
|---|---|---|
| Diode lasera contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue | Device | Group A Photo-biomodulation pulpotomy with Bioceramic putty, Group B photocoagulation pulpotomy with Bioceramic putty |
| Sodium Hypochlorite SolutionA disinfecting agent used in conventional pulpotomy procedures | Other | Group C(Control) Conventional pulpotomy with Bioceramic putty |
Primary outcome
Assessment of healing progress
Time frame: one year
evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. -
Radiographic assessment of the dentin bridge formation
Time frame: one year
evaluating the dentin bridge formation using periapical radiographs and CBCT
Automated segmentation of the radicular pulp space
Time frame: one year
this will be done using CBCT imaging
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 Dec 2025.
- 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.
Rania Noaman ELbackly, Professor principal investigator
Endodontics, Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser and Sodium Hypochlorite Solution in people with Irreversible Pulpitis (Toothache), run by Rana Hegaz 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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?
Contact Rana Mahmoud Hegazi, Assistant lecturer (01094428209, ranahegazi1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of healing progress (time frame: one year). The study lists 3 primary outcomes in all. 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 Dec 2025.