NecrosisNCT03015987
Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth
A study testing diode laser activated irrigation in people with Necrosis, run by Cairo University.
Trial summary
the investigator intended to study the effect of laser versus ultrasonic in activation of irrigation in post operative pain of patients have a symptomatic necrotic teeth Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrosis
- What is being tested?
- diode laser activated irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Feb 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic necrotic single rooted single canal teeth with or without chronic periradicular lesion.
- Teeth with mature root
- Teeth without calcified root canals
- Teeth without root caries
- Teeth without internal or external root resorption
- Teeth with no sign of crack formation
- Teeth without anatomic abnormalities
Who cannot join
- Pregnant or lactating females
- Teeth with vital pulp
- Non- restorable teeth
- Medically compromised patients
- Patients with facial swelling or acute infection.
- Previously endodontically treated teeth
- periodontally affected teeth
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Diode Laser Activated Irrigation Versus Ultrasonic Activated Irrigation on Post-Operative Pain in Single Visit Endodontic Treatment of Asymptomatic Necrotic Teeth: A Randomized Controlled Trial
the investigator intended to study the effect of laser versus ultrasonic in activation of irrigation in post operative pain of patients have a symptomatic necrotic teeth
Read the detailed description
the investigator will choose from patients entering clinic of endodontics in faculty of oral and dental medicine Cairo university who are eligible to the criteria.
After the patients is found eligible,the patients will be randomly assigned to either the control (ultrasonic activated irrigation )or to the intervention ( diode laser activated irrigation) treatment done in both in single visit.
At the end of treatment, patients will be asked to record post operative pain by NRS .
- Conditions
- Necrosis
- Being tested
- diode laser activated irrigation
- Keywords
- Diode laser, asymptomatic pulp, Laser activated irrigation, continuous ultrasonic activation, post obturation pain
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laser activated irrigationOther
Also called diode laser
diode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that
| Study group | Role | What they receive |
|---|---|---|
| diode laser activated irrigation | Experimental | Laser-activated irrigation (LAI) has been introduced as a powerful method enhancing irrigant action; The laser radiation produces transient cavitation in the liquid through optical breakdown by strong absorption of the laser energy. The high-power diode laser has been tested in several areas of dentistry such as bleaching, depigmentation and gingivectomy, with promising results in dentinal disinfection. The diode laser has proved to be a resource worth testing, because of the it's properties and its low cost and availability in comparison to most lasers used in endodontics. Receives: Other: diode laser activated irrigation |
| ultrasonic activated irrigation | Active comparator | ultrasonics have been developed to improve the penetration and effectiveness of irrigation in peripheral areas of the root canal space. The efficiency of sonic and ultrasonic devices is based on the creation of hydrodynamic phenomenon in well-shaped canals filled with an irrigant.
Such active root canal irrigation has been shown to facilitate the disruption of biofilms and make the cell membrane of bacteria more permeable to NaOCl. Receives: Other: diode laser activated irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
intensity of post operative pain will be measured using a numerical rating (NRS)scale
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionJan 2018 (estimated)
- Study completionFeb 2018 (estimated)
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 NecrosisStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zeinab mostafa omar, Cairo University
- Investigators
- Ghada A Eid, Professor, Study chair, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo universityHanaa M El shinawy, Researcher professor, Study director, Surgery &oral medicine department -National Research Institute-Cairo UniversityZeinab M Omar, Student, Principal investigator, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015987
- Sponsor's protocol ID
- laser_ultrasonic
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
1-Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J 2008; 41:91-9. 2-.Ng YL, Glennon JP, Setchell DJ. Prevalence of and factors affecting post. obturation pain in patients undergoing root canal treatment. Int Endod J 2004;37:381-91. 3-Peters OA. Current challenges and concepts in the preparation of root canal systems a review. J Endod 2004; 30:559-67. 4- Gu L, Kim JR, Ling J. Review of contemporary irrigant agitation techniques and devices. J Endod 2009; 35:791-804.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diode Laser Activated Irrigation Versus Ultrasonic Activated Irrigation on Post-Operative Pain in Single Visit Endodontic Treatment of Asymptomatic Necrotic Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03015987
- Acronym / sponsor ID
- laser_ultrasonic
- Conditions
- Necrosis
- Keywords
- Diode laser, asymptomatic pulp, Laser activated irrigation, continuous ultrasonic activation, post obturation pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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 investigator intended to study the effect of laser versus ultrasonic in activation of irrigation in post operative pain of patients have a symptomatic necrotic teeth
Detailed description
the investigator will choose from patients entering clinic of endodontics in faculty of oral and dental medicine Cairo university who are eligible to the criteria.
After the patients is found eligible,the patients will be randomly assigned to either the control (ultrasonic activated irrigation )or to the intervention ( diode laser activated irrigation) treatment done in both in single visit.
At the end of treatment, patients will be asked to record post operative pain by NRS .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diode laser activated irrigation | Experimental | Other: diode laser activated irrigationLaser-activated irrigation (LAI) has been introduced as a powerful method enhancing irrigant action; The laser radiation produces transient cavitation in the liquid through optical breakdown by strong absorption of the laser energy. The high-power diode laser has been tested in several areas of dentistry such as bleaching, depigmentation and gingivectomy, with promising results in dentinal disinfection. The diode laser has proved to be a resource worth testing, because of the it's properties and its low cost and availability in comparison to most lasers used in endodontics. |
| ultrasonic activated irrigation | Active comparator | Other: diode laser activated irrigationultrasonics have been developed to improve the penetration and effectiveness of irrigation in peripheral areas of the root canal space. The efficiency of sonic and ultrasonic devices is based on the creation of hydrodynamic phenomenon in well-shaped canals filled with an irrigant. Such active root canal irrigation has been shown to facilitate the disruption of biofilms and make the cell membrane of bacteria more permeable to NaOCl. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Asymptomatic necrotic single rooted single canal teeth with or without chronic periradicular lesion.
- Teeth with mature root
- Teeth without calcified root canals
- Teeth without root caries
- Teeth without internal or external root resorption
Key exclusion criteria (7 listed)
- Pregnant or lactating females
- Teeth with vital pulp
- Non- restorable teeth
- Medically compromised patients
- Patients with facial swelling or acute infection.
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 laser activated irrigationAlso: diode laserdiode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that | Other | diode laser activated irrigation, ultrasonic activated irrigation |
Primary outcome
post operative pain
Time frame: up to 1 week
intensity of post operative pain will be measured using a numerical rating (NRS)scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background1-Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J 2008; 41:91-9. 2-.Ng YL, Glennon JP, Setchell DJ. Prevalence of and factors affecting post. obturation pain in patients undergoing root canal treatment. Int Endod J 2004;37:381-91. 3-Peters OA. Current challenges and concepts in the preparation of root canal systems a review. J Endod 2004; 30:559-67. 4- Gu L, Kim JR, Ling J. Review of contemporary irrigant agitation techniques and devices. J Endod 2009; 35:791-804.
- 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.
Ghada A Eid, Professor study chair
Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
Hanaa M El shinawy, Researcher professor study director
Surgery &oral medicine department -National Research Institute-Cairo University
Zeinab M Omar, Student principal investigator
Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
Questions about this trial
What is this clinical trial studying?
A study testing diode laser activated irrigation in people with Necrosis, 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 7 inclusion and 7 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 11 Jan 2017. 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. 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 Zeinab M Omar, student (01017111154, dentistonline89@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain (time frame: up to 1 week). 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 NCT03015987, 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 11 Jan 2017.