Symptomatic Irreversible Pulpitis and Post Operative PainLASERPULPNCT07850258
Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
A study testing Conventional Total Pulpotomy and Laser-Assisted Total Pulpotomy in people with Symptomatic Irreversible Pulpitis and Post Operative Pain, run by meliksahgunduz at 1 site in Turkey (Türkiye).
Trial summary
his randomized controlled clinical trial will compare laser-assisted total pulpotomy with conventional total pulpotomy in permanent molar teeth diagnosed with symptomatic irreversible pulpitis. Participants will be randomly assigned to one of two treatment groups. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis and Post Operative Pain
- What is being tested?
- Conventional Total Pulpotomy and Laser-Assisted Total 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 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Jul 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants aged 12-40 years
- Systemically healthy individuals classified as ASA I or ASA II
- Permanent molar teeth
- Teeth suitable for rubber dam isolation
- Diagnosis of symptomatic irreversible pulpitis
- Presence of spontaneous pain and/or prolonged response to thermal stimuli
Show all 10Show fewer
- Pain persisting for more than 10 seconds after cold testing
- Positive pulp sensibility, supported by electric pulp testing
- Normal or minimally altered periapical status with a Periapical Index (PAI) score ≤2
- Final diagnosis confirmed based on combined clinical and radiographic findings
Who cannot join
- Presence of sinus tract, abscess, or swelling
- Internal or external root resorption
- Pathological tooth mobility
- Periodontally compromised teeth, including probing depth ≥4 mm and/or -clinical attachment loss
- Pulp necrosis or negative pulp sensibility tests
- Absence of bleeding after pulp exposure
Show all 12Show fewer
- More than one carious tooth in the same region
- Anterior or premolar teeth
- Antibiotic use within the previous 1 week
- Immunosuppressed patients
- Patients unable to provide consent
- Patients younger than 12 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya health sciences university faculty of dentistry
Kütahya, Merkez, 43100
melikşah gündüz, assistant prof., +905326389337, meliksah.gunduz@ksbu.edu.tr
About this study
Official title: Laser-assisted Versus Conventional Total Pulpotomy for Postoperative Pain and Clinical-Radiographic Outcomes in Mature Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
his randomized controlled clinical trial will compare laser-assisted total pulpotomy with conventional total pulpotomy in permanent molar teeth diagnosed with symptomatic irreversible pulpitis. Participants will be randomly assigned to one of two treatment groups. In the conventional group, bleeding control will be achieved using sodium hypochlorite, whereas in the laser-assisted group, an Er:YAG laser will be used for hemostasis. In both groups, Biodentine will be placed over the remaining pulp tissue and the tooth will be permanently restored.
Postoperative pain will be assessed using a visual analog scale at 6, 12, and 24 hours and on days 3, 5, and 7 after treatment. Clinical and radiographic outcomes will also be evaluated during follow-up to determine treatment success. The study aims to determine whether laser-assisted total pulpotomy differs from conventional total pulpotomy in terms of postoperative pain and clinical and radiographic outcomes.
Read the detailed description
Symptomatic irreversible pulpitis is commonly associated with spontaneous or prolonged pain; however, the presence of severe symptoms does not necessarily indicate that the entire pulp has lost its capacity for healing. Total pulpotomy is a vital pulp treatment intended to preserve the remaining radicular pulp tissue while removing the inflamed coronal pulp. The use of Er:YAG laser irradiation may provide additional hemostatic and tissue-related effects during vital pulp treatment.
In this prospective randomized controlled clinical trial, eligible participants aged 12 to 40 years with permanent molar teeth diagnosed with symptomatic irreversible pulpitis will be randomly allocated to conventional total pulpotomy or laser-assisted total pulpotomy. After local anesthesia, rubber dam isolation, caries removal, and removal of the coronal pulp tissue to the level of the canal orifices, the assigned hemostasis protocol will be performed.
In the conventional total pulpotomy group, hemostasis will be achieved using a cotton pellet moistened with 2.5% sodium hypochlorite. In the laser-assisted group, hemostasis will be achieved using an Er:YAG laser. After hemostasis, approximately 2 mm of Biodentine will be placed over the pulp tissue, followed by a glass ionomer base and composite resin restoration in both groups.
Postoperative pain intensity will be recorded using a visual analog scale at 6, 12, and 24 hours and on days 3, 5, and 7. Clinical follow-up will include assessment of spontaneous pain, percussion and palpation tenderness, swelling or sinus tract formation, and abnormal mobility. Radiographic evaluation will assess the periapical and furcation regions. Clinical follow-up visits are planned at 3, 6, and 12 months, with radiographic evaluation at baseline and 12 months. Treatment will be considered successful when predefined clinical and radiographic success criteria are met.
- Being tested
- Conventional Total Pulpotomy, Laser-Assisted Total Pulpotomy
- Keywords
- Total Pulpotomy, Vital Pulp Therapy, Er:YAG Laser, Postoperative Pain, Clinical and Radiographic Outcomes
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Total PulpotomyProcedure or surgery
Following removal of the coronal pulp tissue to the level of the canal orifices, initial bleeding control will be performed using a saline-moistened cotton pellet. Hemostasis will then be achieved using a cotton pellet moistened with 2.5% sodium hypochlorite for 2 minutes and repeated if necessary, without exceeding a total application time of 5 minutes. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration.
Laser-Assisted Total PulpotomyProcedure or surgery
Following removal of the coronal pulp tissue to the level of the canal orifices, initial bleeding control will be performed using a saline-moistened cotton pellet. Hemostasis will then be achieved using an Er:YAG laser (2940 nm) with an H14 handpiece in SP mode at 20 mJ, 15 Hz, and 0.3 W. The laser will be applied approximately 1 mm from the pulp surface using a sweeping motion for 15 seconds and repeated until complete hemostasis is achieved. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Total Pulpotomy | Active comparator | Participants assigned to this arm will receive conventional total pulpotomy. After removal of the coronal pulp tissue, initial bleeding control will be performed with a saline-moistened cotton pellet, followed by hemostasis using a cotton pellet moistened with 2.5% sodium hypochlorite. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration. Receives: Procedure: Conventional Total Pulpotomy |
| Laser-Assisted Total Pulpotomy | Experimental | Participants assigned to this arm will receive laser-assisted total pulpotomy. After removal of the coronal pulp tissue, initial bleeding control will be performed with a saline-moistened cotton pellet, followed by hemostasis using an Er:YAG laser. After laser-assisted hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration. Receives: Procedure: Laser-Assisted Total Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Participants will record their pain scores using the provided follow-up forms.
Measured: 6, 12, and 24 hours and 3, 5, and 7 days after treatment
Secondary outcomes (2)
Clinical Success of Total Pulpotomy
Clinical success will be assessed based on the absence of spontaneous pain, tenderness to percussion or palpation, swelling or sinus tract formation, and increased pathological mobility. Teeth meeting all predefined clinical success criteria will be considered clinically successful.
Measured: 3, 6, and 12 months after treatment
Radiographic Success of Total Pulpotomy
Radiographic success will be assessed using periapical radiographs. Success will be defined as the absence of new furcation or periapical lesions, maintenance of lamina dura continuity, and, when a mild pre-existing lesion is present, evidence of radiographic healing.
Measured: 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 posted30 Sep 2026
- Study start1 May 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 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 Pulpitis and Post Operative PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- meliksahgunduz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, meliksahgunduz, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850258
- Sponsor's protocol ID
- SIP-PT-01
- Acronym
- LASERPULP
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser-assisted Versus Conventional Total Pulpotomy for Postoperative Pain and Clinical-Radiographic Outcomes in Mature Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07850258
- Acronym / sponsor ID
- LASERPULP / SIP-PT-01
- Keywords
- Total Pulpotomy, Vital Pulp Therapy, Er:YAG Laser, Postoperative Pain, Clinical and Radiographic Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- meliksahgunduzUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Sep 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.
his randomized controlled clinical trial will compare laser-assisted total pulpotomy with conventional total pulpotomy in permanent molar teeth diagnosed with symptomatic irreversible pulpitis. Participants will be randomly assigned to one of two treatment groups. In the conventional group, bleeding control will be achieved using sodium hypochlorite, whereas in the laser-assisted group, an Er:YAG laser will be used for hemostasis. In both groups, Biodentine will be placed over the remaining pulp tissue and the tooth will be permanently restored.
Postoperative pain will be assessed using a visual analog scale at 6, 12, and 24 hours and on days 3, 5, and 7 after treatment. Clinical and radiographic outcomes will also be evaluated during follow-up to determine treatment success. The study aims to determine whether laser-assisted total pulpotomy differs from conventional total pulpotomy in terms of postoperative pain and clinical and radiographic outcomes.
Detailed description
Symptomatic irreversible pulpitis is commonly associated with spontaneous or prolonged pain; however, the presence of severe symptoms does not necessarily indicate that the entire pulp has lost its capacity for healing. Total pulpotomy is a vital pulp treatment intended to preserve the remaining radicular pulp tissue while removing the inflamed coronal pulp. The use of Er:YAG laser irradiation may provide additional hemostatic and tissue-related effects during vital pulp treatment.
In this prospective randomized controlled clinical trial, eligible participants aged 12 to 40 years with permanent molar teeth diagnosed with symptomatic irreversible pulpitis will be randomly allocated to conventional total pulpotomy or laser-assisted total pulpotomy. After local anesthesia, rubber dam isolation, caries removal, and removal of the coronal pulp tissue to the level of the canal orifices, the assigned hemostasis protocol will be performed.
In the conventional total pulpotomy group, hemostasis will be achieved using a cotton pellet moistened with 2.5% sodium hypochlorite. In the laser-assisted group, hemostasis will be achieved using an Er:YAG laser. After hemostasis, approximately 2 mm of Biodentine will be placed over the pulp tissue, followed by a glass ionomer base and composite resin restoration in both groups.
Postoperative pain intensity will be recorded using a visual analog scale at 6, 12, and 24 hours and on days 3, 5, and 7. Clinical follow-up will include assessment of spontaneous pain, percussion and palpation tenderness, swelling or sinus tract formation, and abnormal mobility. Radiographic evaluation will assess the periapical and furcation regions. Clinical follow-up visits are planned at 3, 6, and 12 months, with radiographic evaluation at baseline and 12 months. Treatment will be considered successful when predefined clinical and radiographic success criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Total Pulpotomy | Active comparator | Procedure: Conventional Total PulpotomyParticipants assigned to this arm will receive conventional total pulpotomy. After removal of the coronal pulp tissue, initial bleeding control will be performed with a saline-moistened cotton pellet, followed by hemostasis using a cotton pellet moistened with 2.5% sodium hypochlorite. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration. |
| Laser-Assisted Total Pulpotomy | Experimental | Procedure: Laser-Assisted Total PulpotomyParticipants assigned to this arm will receive laser-assisted total pulpotomy. After removal of the coronal pulp tissue, initial bleeding control will be performed with a saline-moistened cotton pellet, followed by hemostasis using an Er:YAG laser. After laser-assisted hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Participants aged 12-40 years
- Systemically healthy individuals classified as ASA I or ASA II
- Permanent molar teeth
- Teeth suitable for rubber dam isolation
- Diagnosis of symptomatic irreversible pulpitis
Key exclusion criteria (12 listed)
- Presence of sinus tract, abscess, or swelling
- Internal or external root resorption
- Pathological tooth mobility
- Periodontally compromised teeth, including probing depth ≥4 mm and/or -clinical attachment loss
- Pulp necrosis or negative pulp sensibility tests
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 |
|---|---|---|
| Conventional Total PulpotomyFollowing removal of the coronal pulp tissue to the level of the canal orifices, initial bleeding control will be performed using a saline-moistened cotton pellet. Hemostasis will then be achieved using a cotton pellet moistened with 2.5% sodium hypochlorite for 2 minutes and repeated if necessary, without exceeding a total application time of 5 minutes. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration. | Procedure or surgery | Conventional Total Pulpotomy |
| Laser-Assisted Total PulpotomyFollowing removal of the coronal pulp tissue to the level of the canal orifices, initial bleeding control will be performed using a saline-moistened cotton pellet. Hemostasis will then be achieved using an Er:YAG laser (2940 nm) with an H14 handpiece in SP mode at 20 mJ, 15 Hz, and 0.3 W. The laser will be applied approximately 1 mm from the pulp surface using a sweeping motion for 15 seconds and repeated until complete hemostasis is achieved. After hemostasis, approximately 2 mm of Biodentine will be placed over the remaining pulp tissue, followed by a glass ionomer base and composite resin restoration. | Procedure or surgery | Laser-Assisted Total Pulpotomy |
Primary outcome
Postoperative Pain Intensity
Time frame: 6, 12, and 24 hours and 3, 5, and 7 days after treatment
Postoperative pain intensity will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Participants will record their pain scores using the provided follow-up forms.
2 secondary outcomes
Clinical Success of Total Pulpotomy
Time frame: 3, 6, and 12 months after treatment
Radiographic Success of Total Pulpotomy
Time frame: 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 30 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Total Pulpotomy and Laser-Assisted Total Pulpotomy in people with Symptomatic Irreversible Pulpitis and Post Operative Pain, run by meliksahgunduz at 1 site in Turkey (Türkiye).
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 10 inclusion and 12 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 30 Sep 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 Turkey (Türkiye). 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 melikşah gündüz, assistant prof. (+905326389337, meliksah.gunduz@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 6, 12, and 24 hours and 3, 5, and 7 days 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 30 Sep 2026.