Periapical DiseasesNCT04315259
Efficiency of Diode Laser in Control of Post-endodontic Pain
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. 180 eligible patients were selected and included in the study to assess the post-endodontic pain of diode laser activated irrigation versus soft tissue diode laser application post obturation versus conventional… 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
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 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 in Control of Post-endodontic Pain (A Randomized Clinical Trial )
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt.
180 eligible patients were selected and included in the study to assess the post-endodontic pain of diode laser activated irrigation versus soft tissue diode laser application post obturation versus conventional root canal treatment .
Read the detailed description
Sample size is 180 180 Patients were randomly distributed in 3 groups , one group of patients received laser therapy after root canal treatment and the other group received disinfection by Diode laser activated irrigation , the third group received no treatment just conventional Root canal treatment. • Patients were equally divided into 3 groups (n=60 in each group ) The study in a Single blinded Randomized clinical trial
, 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 have a laser session following root canal treatment to test its ability to control pain , the consent will also require them to take a questionnaire at home to measure their pain level and they were willingly do it.
Conventional root canal treatment were done to selected teeth , and any cases with procedural errors were excluded.
Group A Laser activated irrigation :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 5s 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 Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group C : conventional root canal treatment : no laser intervention Patients were instructed to record their post-endodontic pain by VAS where 0 stands for no pain and 10 stands for severe pain.
- Conditions
- Periapical Diseases
- Being tested
- Diode laser
- Keywords
- Diode laser, low 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 Low laser therapy, soft laser, Lite medics serial number 148 Ver.SwvM. 150VS108VT.100
irrigation activated by diode laser versus soft tissue laser application therapy
| Study group | Role | What they receive |
|---|---|---|
| Laser activated irrigation | Experimental | conventional root canal treatment was done , 2.5% sodium hypochlorite was used and was activated by 980 nm with a repeated pulse mode using a pulse duration of 5 s and a pulse interval of 0.2 ms. The laser irradiation will be 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 (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) Receives: Device: Diode laser |
| Soft tissue laser application | Experimental | Endodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices.
Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product Receives: Device: Diode laser |
| conventional root canal | No intervention | conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with no laser intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Measured: 24 hours
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Measured: 48 hours
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 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.
- 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
- 180 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
- NCT04315259
- Sponsor's protocol ID
- END 16-13D
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- 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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Diode Laser in Control of Post-endodontic Pain (A Randomized Clinical Trial )
- ClinicalTrials.gov ID
- NCT04315259
- Acronym / sponsor ID
- END 16-13D
- Conditions
- Periapical Diseases
- Keywords
- Diode laser, low laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 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
- 19 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.
180 eligible patients were selected and included in the study to assess the post-endodontic pain of diode laser activated irrigation versus soft tissue diode laser application post obturation versus conventional root canal treatment .
Detailed description
Sample size is 180 180 Patients were randomly distributed in 3 groups , one group of patients received laser therapy after root canal treatment and the other group received disinfection by Diode laser activated irrigation , the third group received no treatment just conventional Root canal treatment. • Patients were equally divided into 3 groups (n=60 in each group ) The study in a Single blinded Randomized clinical trial
, 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 have a laser session following root canal treatment to test its ability to control pain , the consent will also require them to take a questionnaire at home to measure their pain level and they were willingly do it.
Conventional root canal treatment were done to selected teeth , and any cases with procedural errors were excluded.
Group A Laser activated irrigation :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 5s 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 Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group C : conventional root canal treatment : no laser intervention Patients were instructed to record their post-endodontic pain by VAS where 0 stands for no pain and 10 stands for severe pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser activated irrigation | Experimental | Device: Diode laserconventional root canal treatment was done , 2.5% sodium hypochlorite was used and was activated by 980 nm with a repeated pulse mode using a pulse duration of 5 s and a pulse interval of 0.2 ms. The laser irradiation will be 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 (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) |
| Soft tissue laser application | Experimental | Device: Diode laserEndodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product |
| conventional root canal | No intervention | –conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with no laser intervention |
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: Low laser therapy, soft laser, Lite medics serial number 148 Ver.SwvM. 150VS108VT.100irrigation activated by diode laser versus soft tissue laser application therapy | Device | Laser activated irrigation, Soft tissue laser application |
Primary outcome
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Time frame: 24 hours
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Time frame: 48 hours
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Time frame: 72 hours
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 19 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Periapical Diseases
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
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 19 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. 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?
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 19 Mar 2020.