Effect of Photobiomodulation Using Diode LaserNCT06396130
The Effect of Photobiomodulation Using Low-Level Diode Laser Therapy on Postoperative Pain in Symptomatic Lower Molar Teeth With Irreversible Pulpitis and Apical Periodontitis; a Randomized Controlled Clinical Trial
A study testing Photobiomodulation by low level diode laser and Mock Laser Application in people with Effect of Photobiomodulation Using Diode Laser, run by Cairo University.
Trial summary
this study aims to assess the effect of photobiomodulation using low-level diode laser therapy on postoperative pain after single-visit root canal treatment of mandibular molars with symptomatic irreversible pulpitis and apical periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Photobiomodulation Using Diode Laser
- What is being tested?
- Photobiomodulation by low level diode laser and Mock Laser Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2024to 29 May 2025
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- . Mature multirooted mandibular molar teeth with: i. Pre-operative sharp pain marked on the VAS scale by reading not less than 6. ii. Clinical diagnosis of symptomatic irreversible pulpitis with periapical periodontitis.
- Normal periapical radiographic appearance or slight widening in lamina dura. iv. Positive response and pain provoked by percussion.
- Patients who agree to provide written consent and attend for recall appointments.
Who cannot join
- Patients who used NSAIDs in the 24 hours before treatment.
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Pregnant or nursing females. 5. Teeth that have:
- Periodontal affection (with pocket depth greater than 5mm, associated with swelling orfistulous tract, or greater than grade I mobility).
- No possible restorability. iii. Signs of pulpal necrosis; associated sinus tract or swelling.
Trial locations and contacts
No sites are listed yet.
About this study
this study aims to assess the effect of photobiomodulation using low-level diode laser therapy on postoperative pain after single-visit root canal treatment of mandibular molars with symptomatic irreversible pulpitis and apical periodontitis.
- Being tested
- Photobiomodulation by low level diode laser, Mock Laser Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation by low level diode laserDevice
Diode laser exposure (Lite Medics 1.00-Watt serial number 148 Ver. SwvM. 150VS108VT.100) will be carried out using a continuous mode with 10 Hz frequency, 980 nm wavelength, and max power 15 WCW. The tip will be applied both at the buccal and the lingual side for 30 s each.
Mock Laser ApplicationOther
Placebo for control group
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation using diode laser | Experimental | Irradiation of periapical tissues with low level diode laser therapy buccally and lingually Receives: Device: Photobiomodulation by low level diode laser |
| Placebo/ Mock Laser | Placebo comparator | Application of laser probe without device activation Receives: Other: Mock Laser Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
Using modified VAS
Measured: 24, 48 and 72 hours
Secondary outcomes (1)
Total number of analgesic tablets taken in case of intolerable pain
Counted and recorded by the patient on a special table.
Measured: Post instrumentation at 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Apr 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Photobiomodulation Using Diode LaserStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour ElGendi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396130
- Sponsor's protocol ID
- ENDO 3-3-5 (29/4/24)
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Photobiomodulation Using Low-Level Diode Laser Therapy on Postoperative Pain in Symptomatic Lower Molar Teeth With Irreversible Pulpitis and Apical Periodontitis; a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06396130
- Acronym / sponsor ID
- ENDO 3-3-5 (29/4/24)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 2 May 2024 (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 aims to assess the effect of photobiomodulation using low-level diode laser therapy on postoperative pain after single-visit root canal treatment of mandibular molars with symptomatic irreversible pulpitis and apical periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation using diode laser | Experimental | Device: Photobiomodulation by low level diode laserIrradiation of periapical tissues with low level diode laser therapy buccally and lingually |
| Placebo/ Mock Laser | Placebo comparator | Other: Mock Laser ApplicationApplication of laser probe without device activation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- . Mature multirooted mandibular molar teeth with: i. Pre-operative sharp pain marked on the VAS scale by reading not less than 6. ii. Clinical diagnosis of symptomatic irreversible pulpitis with periapical periodontitis.
- Normal periapical radiographic appearance or slight widening in lamina dura. iv. Positive response and pain provoked by percussion.
- Patients who agree to provide written consent and attend for recall appointments.
Key exclusion criteria (6 listed)
- Patients who used NSAIDs in the 24 hours before treatment.
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Pregnant or nursing females. 5. Teeth that have:
- No possible restorability. iii. Signs of pulpal necrosis; associated sinus tract or swelling.
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 |
|---|---|---|
| Photobiomodulation by low level diode laserDiode laser exposure (Lite Medics 1.00-Watt serial number 148 Ver. SwvM. 150VS108VT.100) will be carried out using a continuous mode with 10 Hz frequency, 980 nm wavelength, and max power 15 WCW. The tip will be applied both at the buccal and the lingual side for 30 s each. | Device | Photobiomodulation using diode laser |
| Mock Laser ApplicationPlacebo for control group | Other | Placebo/ Mock Laser |
Primary outcome
Intensity of postoperative pain
Time frame: 24, 48 and 72 hours
Using modified VAS
1 secondary outcome
Total number of analgesic tablets taken in case of intolerable pain
Time frame: Post instrumentation at 24, 48 and 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation by low level diode laser and Mock Laser Application in people with Effect of Photobiomodulation Using Diode Laser, run by Cairo University.
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 3 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: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nour ElGendi, Bds (01001753319 ext. 002, nour.elgendi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of postoperative pain (time frame: 24, 48 and 72 hours). 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 2 May 2024.