Periapical DiseasesNCT04311905
Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues
A study testing Diode laser in people with Periapical Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of diode laser activated irrigation versus conventional root canal treatment using CBCT Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Jan 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients age between 18-50 years
- Medically free patients.
- Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
- Preoperative Pain
- Sensitivity to percussion
- Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
- Occlusal contact with opposing teeth
Who cannot join
- Pregnant females.
- Patients having a significant systemic disorder or history of drug abuse
- Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching
- Teeth having:
- No occlusal contact
Show all 13Show fewer
- No sensitivity to percussion
- Greater than grade I mobility.
- Pocket depth greater than 5mm.
- No possible restorability
- Procedural errors
- Previous Root canal treatment
- Open apex
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Endodontic department - Faculty of Dentistry Ainshams University
Cairo
About this study
Official title: Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues (A Randomized Clinical Trial )
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of diode laser activated irrigation versus conventional root canal treatment using CBCT
Read the detailed description
Sample size is 24 , 24 Patients were randomly distributed in 2 groups , one group of patients received laser activated irrigation LAI during root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not receive a laser activated irrigation Group A LAI :Disinfection were done by using 5 ml of 2.5% sodium hypochlorite irrigation for 1 minute. Irrigation will be performed with a 30-gauge needle side vented The irrigation needles were introduced passively up to 2 mm away the working length. After irrigation Laser treatment will be performed with a diode laser, at a wavelength of 980 nm with a repeated pulse mode using a pulse duration of 5sec per canal and a pulse interval of 0.2 ms. The laser irradiation were delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part Group B : received mock laser intervention , conventional Root canal treatment with 2.5% sodium hypochlorite CBCT was taken pre-operative and another one was taken after 12 month , both volumetric and linear measurements were calculated
- Conditions
- Periapical Diseases
- Being tested
- Diode laser, Placebo
- Keywords
- Diode laser, CBCT, low level laser therapy
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Also called LAI
Diode laser activated irrigation
PlaceboOther
mock Laser activated irrigation
| Study group | Role | What they receive |
|---|---|---|
| Laser activated irrigation LAI | Experimental | Diode Laser activated irrigation Receives: Device: Diode laser |
| conventional root canal treatment | Placebo comparator | mock LAI , conventional root canal treatment 2.5% sodium hypochlorite Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess post-operative healing using CBCT in a period of 12 month when Laser activated irrigation was used during root canal treatment
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 posted17 Mar 2020
- Study start1 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Hamdy Ismail, Ain Shams University
- Investigators
- Maram Obeid, PhD, Study director, AinShams UniversityEhab Hassanien, PhD, Study chair, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311905
- Sponsor's protocol ID
- END 16-15D
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamdy Ismail H, Obeid MF, ElSaid Hassanein E. The efficiency of single-session photobiomodulation on healing of periapical bone lesions using CBCT: a randomized clinical trial. Lasers Med Sci. 2025 Jan 23;40(1):31. doi: 10.1007/s10103-024-04242-5.
PubMed 39847087
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues (A Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT04311905
- Acronym / sponsor ID
- END 16-15D
- Conditions
- Periapical Diseases
- Keywords
- Diode laser, CBCT, low level laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Mar 2020 (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.
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of diode laser activated irrigation versus conventional root canal treatment using CBCT
Detailed description
Sample size is 24 , 24 Patients were randomly distributed in 2 groups , one group of patients received laser activated irrigation LAI during root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not receive a laser activated irrigation Group A LAI :Disinfection were done by using 5 ml of 2.5% sodium hypochlorite irrigation for 1 minute. Irrigation will be performed with a 30-gauge needle side vented The irrigation needles were introduced passively up to 2 mm away the working length. After irrigation Laser treatment will be performed with a diode laser, at a wavelength of 980 nm with a repeated pulse mode using a pulse duration of 5sec per canal and a pulse interval of 0.2 ms. The laser irradiation were delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part Group B : received mock laser intervention , conventional Root canal treatment with 2.5% sodium hypochlorite CBCT was taken pre-operative and another one was taken after 12 month , both volumetric and linear measurements were calculated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser activated irrigation LAI | Experimental | Device: Diode laserDiode Laser activated irrigation |
| conventional root canal treatment | Placebo comparator | Other: Placebomock LAI , conventional root canal treatment 2.5% sodium hypochlorite |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult patients age between 18-50 years
- Medically free patients.
- Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
- Preoperative Pain
- Sensitivity to percussion
Key exclusion criteria (13 listed)
- Pregnant females.
- Patients having a significant systemic disorder or history of drug abuse
- Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching
- Teeth having:
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 laserAlso: LAIDiode laser activated irrigation | Device | Laser activated irrigation LAI |
| Placebomock Laser activated irrigation | Other | conventional root canal treatment |
Primary outcome
Assess post-operative healing using CBCT in a period of 12 month when Laser activated irrigation was used during root canal treatment
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 18 Mar 2020.
- Derived from this study: PubMed 39847087Hamdy Ismail H, Obeid MF, ElSaid Hassanein E. The efficiency of single-session photobiomodulation on healing of periapical bone lesions using CBCT: a randomized clinical trial. Lasers Med Sci. 2025 Jan 23;40(1):31. doi: 10.1007/s10103-024-04242-5.
- 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. This study is not recruiting at the moment.
Maram Obeid, PhD study director
AinShams University
Ehab Hassanien, PhD study chair
Ainshams University
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 in people with Periapical Diseases, run by Ain Shams 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 7 inclusion and 13 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 18 Mar 2020. 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. 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?
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?
Assess post-operative healing using CBCT in a period of 12 month when Laser activated irrigation was used during root canal treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311905, which also lists 1 linked publication.
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 18 Mar 2020.