Irreversible Pulpitis (Toothache)NCT07761962
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
A study testing Diode laser full pulpotomy and Sodium hypochlorite pulpotomy in people with Irreversible Pulpitis (Toothache), run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
This study compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp. In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis (Toothache)
- What is being tested?
- Diode laser full pulpotomy and Sodium hypochlorite pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJordan
- Study dates
- 23 Oct 2025to Jun 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Non -contributory medical history (SAI, II).
- Premolar or Molar permanent tooth
- Age range 10-60 years
- Deep caries extending>= 2/3 of dentin or exposing the pulp on the radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of irreversible pulpitis based on the symptoms and results of cold testing.
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- No signs of pulpal necrosis including sinus tract or swelling
Who cannot join
- Medically compromised patient.
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- No enough bleeding after the pulpotomy procedure.
- Inability to achieve hemostasis within 10 min after the pulpotomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Diode Laser-Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
This study compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp.
In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution.
Read more
In the second method, the dentist also removes the affected pulp tissue using a high-speed dental bur, but a diode laser is used to control the bleeding. The laser may provide additional disinfection and achieve bleeding control more quickly.
After treatment, participants will be monitored to assess their level of pain relief. They will also return for follow-up visits at 6 months and 12 months, when dental X-rays will be taken to evaluate the success of the treatment.
Read the detailed description
Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the vitality and function of the dental pulp after exposure caused by deep caries. Compared with root canal treatment, VPT preserves the remaining healthy pulp tissue, allowing the tooth to maintain its natural defense mechanisms and reparative capacity. Full pulpotomy has become an accepted treatment option for permanent teeth with carious pulp exposure when the radicular pulp is considered healthy and capable of healing. Clinical studies have demonstrated high success rates for full pulpotomy in appropriately selected cases.
Successful pulpotomy depends on adequate removal of the inflamed coronal pulp tissue, effective control of pulpal bleeding, reduction of bacterial contamination, and placement of a suitable biocompatible pulp-capping material. Conventionally, hemostasis is achieved using sodium hypochlorite following removal of the coronal pulp tissue with a high-speed bur. Although this technique has demonstrated favorable outcomes, alternative methods that may improve hemostasis and enhance tissue healing continue to be investigated.
Diode lasers have been increasingly used in dentistry for soft tissue procedures because of their ability to provide precise tissue interaction, coagulation, and effective hemostasis. In addition to controlling bleeding, diode lasers have antimicrobial properties and may promote wound healing through biostimulatory effects that support tissue repair and reparative dentin formation. These characteristics suggest that diode laser-assisted pulpotomy may offer clinical advantages over the conventional technique.
Despite the increasing use of diode lasers in dentistry, clinical evidence regarding their use in full pulpotomy of permanent teeth with carious pulp exposure remains limited. Most published studies have evaluated diode laser pulpotomy in primary teeth or animal models, and randomized clinical trials in permanent teeth are lacking.
This randomized clinical trial is designed to compare diode laser-assisted full pulpotomy with the conventional full pulpotomy technique in permanent teeth with carious pulp exposure. In both study groups, the coronal pulp tissue will be removed using a conventional high-speed bur. In the control group, hemostasis will be achieved using sodium hypochlorite. In the experimental group, a diode laser will be used to achieve hemostasis following pulp removal. The same pulp-capping material and definitive restoration protocol will be used in both groups to ensure that the method of achieving hemostasis is the primary variable under investigation.
Participants will be evaluated for postoperative pain following treatment. Clinical and radiographic outcomes will be assessed at 6 and 12 months to determine treatment success. The study aims to determine whether diode laser-assisted full pulpotomy provides clinical and radiographic outcomes comparable to or better than those of the conventional technique.
- Conditions
- Irreversible Pulpitis (Toothache)
- Being tested
- Diode laser full pulpotomy, Sodium hypochlorite pulpotomy
- Keywords
- Carious pulp exposure, Laser, Pulpotomy
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser full pulpotomyProcedure or surgery
The use of diode laser to achieve hemostasis after cutting the coronal part of the pulp tissue which is present in the tooth crown, down to the level of the canal orifices.
Sodium hypochlorite pulpotomyProcedure or surgery
The use of Sodium hypochlorite to achieve hemostasis after full pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| Full pulpotomy using diode laser for hemostasis | Experimental | Diode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue. Receives: Procedure: Diode laser full pulpotomy |
| Full pulpotomy using sodium hypochlorite for hemostasis | Active comparator | The use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices Receives: Procedure: Sodium hypochlorite pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after pulpotomy
Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Participants will record their pain intensity at the prespecified postoperative time points.
Measured: One week after treatment
Secondary outcomes (1)
Success of pulpotomy
Clinical and radiographic success will be evaluated at the follow-up visits. Clinical success is defined as the absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, pathological mobility, or other signs and symptoms indicating pulpal or periapical disease. Radiographic success is defined as the absence of periapical radiolucency, furcation involvement, external or internal root resorption, widening of the periodontal ligament space, or other radiographic evidence of treatment failure.
Measured: Six and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start23 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 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 (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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo full pulpotomy with diode laser-assisted hemostasis, while the control group will undergo conventional full pulpotomy with sodium hypochlorite for hemostasis. Participants will receive only the assigned intervention and will be followed for postoperative pain and clinical and radiographic outcomes at 6 and 12 months.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessrin Taha, Jordan University of Science and Technology
- Investigators
- Nessrin Taha, PhD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761962
- Sponsor's protocol ID
- 510/2025
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 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 because of institutional data-sharing policies and the need to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Diode Laser-Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07761962
- Acronym / sponsor ID
- 510/2025
- Conditions
- Irreversible Pulpitis (Toothache)
- Keywords
- Carious pulp exposure, Laser, Pulpotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 13 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 compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp.
In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution.
In the second method, the dentist also removes the affected pulp tissue using a high-speed dental bur, but a diode laser is used to control the bleeding. The laser may provide additional disinfection and achieve bleeding control more quickly.
After treatment, participants will be monitored to assess their level of pain relief. They will also return for follow-up visits at 6 months and 12 months, when dental X-rays will be taken to evaluate the success of the treatment.
Detailed description
Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the vitality and function of the dental pulp after exposure caused by deep caries. Compared with root canal treatment, VPT preserves the remaining healthy pulp tissue, allowing the tooth to maintain its natural defense mechanisms and reparative capacity. Full pulpotomy has become an accepted treatment option for permanent teeth with carious pulp exposure when the radicular pulp is considered healthy and capable of healing. Clinical studies have demonstrated high success rates for full pulpotomy in appropriately selected cases.
Successful pulpotomy depends on adequate removal of the inflamed coronal pulp tissue, effective control of pulpal bleeding, reduction of bacterial contamination, and placement of a suitable biocompatible pulp-capping material. Conventionally, hemostasis is achieved using sodium hypochlorite following removal of the coronal pulp tissue with a high-speed bur. Although this technique has demonstrated favorable outcomes, alternative methods that may improve hemostasis and enhance tissue healing continue to be investigated.
Diode lasers have been increasingly used in dentistry for soft tissue procedures because of their ability to provide precise tissue interaction, coagulation, and effective hemostasis. In addition to controlling bleeding, diode lasers have antimicrobial properties and may promote wound healing through biostimulatory effects that support tissue repair and reparative dentin formation. These characteristics suggest that diode laser-assisted pulpotomy may offer clinical advantages over the conventional technique.
Despite the increasing use of diode lasers in dentistry, clinical evidence regarding their use in full pulpotomy of permanent teeth with carious pulp exposure remains limited. Most published studies have evaluated diode laser pulpotomy in primary teeth or animal models, and randomized clinical trials in permanent teeth are lacking.
This randomized clinical trial is designed to compare diode laser-assisted full pulpotomy with the conventional full pulpotomy technique in permanent teeth with carious pulp exposure. In both study groups, the coronal pulp tissue will be removed using a conventional high-speed bur. In the control group, hemostasis will be achieved using sodium hypochlorite. In the experimental group, a diode laser will be used to achieve hemostasis following pulp removal. The same pulp-capping material and definitive restoration protocol will be used in both groups to ensure that the method of achieving hemostasis is the primary variable under investigation.
Participants will be evaluated for postoperative pain following treatment. Clinical and radiographic outcomes will be assessed at 6 and 12 months to determine treatment success. The study aims to determine whether diode laser-assisted full pulpotomy provides clinical and radiographic outcomes comparable to or better than those of the conventional technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo full pulpotomy with diode laser-assisted hemostasis, while the control group will undergo conventional full pulpotomy with sodium hypochlorite for hemostasis. Participants will receive only the assigned intervention and will be followed for postoperative pain and clinical and radiographic outcomes at 6 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Full pulpotomy using diode laser for hemostasis | Experimental | Procedure: Diode laser full pulpotomyDiode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue. |
| Full pulpotomy using sodium hypochlorite for hemostasis | Active comparator | Procedure: Sodium hypochlorite pulpotomyThe use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- • Non -contributory medical history (SAI, II).
Key exclusion criteria (5 listed)
- Medically compromised patient.
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 laser full pulpotomyThe use of diode laser to achieve hemostasis after cutting the coronal part of the pulp tissue which is present in the tooth crown, down to the level of the canal orifices. | Procedure or surgery | Full pulpotomy using diode laser for hemostasis |
| Sodium hypochlorite pulpotomyThe use of Sodium hypochlorite to achieve hemostasis after full pulpotomy | Procedure or surgery | Full pulpotomy using sodium hypochlorite for hemostasis |
Primary outcome
Postoperative pain after pulpotomy
Time frame: One week after treatment
Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Participants will record their pain intensity at the prespecified postoperative time points.
1 secondary outcome
Success of pulpotomy
Time frame: Six and 12 months 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 13 Aug 2026.
- Publication on the protocol of pulpotomy published previously by the principal investigatorLink provided by the sponsor.
- A review on the treatment modality and biological bases published by the principal investigatorLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared because of institutional data-sharing policies and the need to protect participant confidentiality.
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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.
Nessrin Taha, PhD study chair
Jordan University of Science and Technology
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 full pulpotomy and Sodium hypochlorite pulpotomy in people with Irreversible Pulpitis (Toothache), run by King Abdullah University Hospital at 1 site in Jordan.
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 5 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 13 Aug 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 Jordan. 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?
Postoperative pain after pulpotomy (time frame: One week after treatment). 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 13 Aug 2026.