Symptomatic Irreversible Pulpitis (SIP)NCT07704463
Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis
A study testing Application of 660 nm diode laser and Application of 970 nm diode laser + MTA in people with Symptomatic Irreversible Pulpitis (SIP), run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Application of 660 nm diode laser and Application of 970 nm diode laser + MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with an age ranging between 6 to 14 years old with no gender predilection.
- Children free of any systemic disease or special health care needs.
- Patients complaining from intermittent or spontaneous, sharp, localized, diffuse, or referred pain.
- Selected teeth should give long lasting positive responses to cold testing.
- Soft tissues around the tooth are normal.
- Periapical radiographs show deep carious lesions.
Show all 9Show fewer
- Patients with immature permanent molars (stages 8 and 9) according to Nolla's classification for tooth developmental stage.
- Periapical index score 1 or 2.
- Following pulpal amputation, hemostasis could be easily achievable within 5 to 10 minutes with a sterile moist cotton pellet.
Who cannot join
- Child with bad experience of dental treatment (uncooperative patient).
- Non-restorable teeth.
- Negative response to cold testing.
- Bleeding could not be controlled.
- Absence of bleeding from any of the canals.
- Pus discharge through an associated sinus tract.
- Pulpal calcifications
- Radiographic signs of internal or external resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis (A Randomized Controlled Clinical Trial )
The goal of this clinical trial is to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.. The main question it aims to answer is:
whether the combined use of Laser pulpotomy with MTA capping material will provide faster healing with acceleration of complete root formation in immature permanent molars compared to MTA pulpotomy alone?
Read more
Participants will:
The coronal inflammed pulp will be carefully amputated to the level of the canal orifices.
Hemostasis will be achieved by gentle placement of a saline-moistened cotton pellet and Placement of capping material will be performed in the study groups.
The post-operative clinical follow up will be done after one week for patient reassurance. Then the postoperative clinical and radiographic follow-up will be scheduled up to twelve months.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Application of 660 nm diode laser, Application of 970 nm diode laser + MTA, Conventional MTA pulpotomy (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of 660 nm diode laserOther
photobiomodulation (PBM) uses low-power irradiation from lasers or light-emitting diode (LED) devices to irradiate human tissues to stimulate dental pulp cells
Application of 970 nm diode laser + MTAOther
Laser application with 970 nm wavelength to penetrate and affect pulpal cells
Conventional MTA pulpotomy (control group)Other
The remaining pulp will be capped with MTA after final rinsing with saline
| Study group | Role | What they receive |
|---|---|---|
| Control group MTA pulpotomy | Active comparator | The remaining pulp will be capped with MTA. Receives: Other: Conventional MTA pulpotomy (control group) |
| Test group 660 nm laser + MTA pulpotomy | Experimental | Application of 660 nm diode laser and the remaining pulp will be capped with MTA. Receives: Other: Application of 660 nm diode laser |
| Test group 970 nm laser +MTA pulpotomy | Experimental | Application of 970 nm diode laser and the remaining pulp will be capped with MTA. Receives: Other: Application of 970 nm diode laser + MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.
Measured: 12 months
Secondary outcomes (1)
1. Evaluation of laser effect on decreasing immediate postoperative pain using Numerical Rating Pain Scale with min (0) No pain - max (10) severe pain. 2. Evaluation of laser effect on dentin bridge formation (if it is radiographically present or not).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jan 2025
- Primary completion1 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704463
- Sponsor's protocol ID
- 0834-01/2024
- Status last verified
- Mar 2025
- First submitted
- 7 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Laser Assisted Pulpotomy in Immature Permanent Molars With Symptoms Indicative of Irreversible Pulpitis (A Randomized Controlled Clinical Trial )
- ClinicalTrials.gov ID
- NCT07704463
- Acronym / sponsor ID
- 0834-01/2024
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 15 Jul 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.
The goal of this clinical trial is to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.. The main question it aims to answer is:
whether the combined use of Laser pulpotomy with MTA capping material will provide faster healing with acceleration of complete root formation in immature permanent molars compared to MTA pulpotomy alone?
Participants will:
The coronal inflammed pulp will be carefully amputated to the level of the canal orifices.
Hemostasis will be achieved by gentle placement of a saline-moistened cotton pellet and Placement of capping material will be performed in the study groups.
The post-operative clinical follow up will be done after one week for patient reassurance. Then the postoperative clinical and radiographic follow-up will be scheduled up to twelve months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group MTA pulpotomy | Active comparator | Other: Conventional MTA pulpotomy (control group)The remaining pulp will be capped with MTA. |
| Test group 660 nm laser + MTA pulpotomy | Experimental | Other: Application of 660 nm diode laserApplication of 660 nm diode laser and the remaining pulp will be capped with MTA. |
| Test group 970 nm laser +MTA pulpotomy | Experimental | Other: Application of 970 nm diode laser + MTAApplication of 970 nm diode laser and the remaining pulp will be capped with MTA. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children with an age ranging between 6 to 14 years old with no gender predilection.
Key exclusion criteria (8 listed)
- Child with bad experience of dental treatment (uncooperative 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 |
|---|---|---|
| Application of 660 nm diode laserphotobiomodulation (PBM) uses low-power irradiation from lasers or light-emitting diode (LED) devices to irradiate human tissues to stimulate dental pulp cells | Other | Test group 660 nm laser + MTA pulpotomy |
| Application of 970 nm diode laser + MTALaser application with 970 nm wavelength to penetrate and affect pulpal cells | Other | Test group 970 nm laser +MTA pulpotomy |
| Conventional MTA pulpotomy (control group)The remaining pulp will be capped with MTA after final rinsing with saline | Other | Control group MTA pulpotomy |
Primary outcome
to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis.
Time frame: 12 months
1 secondary outcome
1. Evaluation of laser effect on decreasing immediate postoperative pain using Numerical Rating Pain Scale with min (0) No pain - max (10) severe pain. 2. Evaluation of laser effect on dentin bridge formation (if it is radiographically present or not).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of 660 nm diode laser and Application of 970 nm diode laser + MTA in people with Symptomatic Irreversible Pulpitis (SIP), run by Alexandria 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to assess the clinical and radiographic success rate of Laser pulpotomy procedure done in immature permanent molars with symptoms indicative of irreversible pulpitis. (time frame: 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 15 Jul 2026.