- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03015987
Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth
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
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: diode laser activated irrigation
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.
|
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
Other Names:
|
|
ACTIVE_COMPARATOR: ultrasonic activated irrigation
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. |
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post operative pain
Time Frame: up to 1 week
|
intensity of post operative pain will be measured using a numerical rating (NRS)scale
|
up to 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ghada A Eid, Professor, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
- Study Director: Hanaa M El shinawy, Researcher professor, Surgery &oral medicine department -National Research Institute-Cairo University
- Principal Investigator: Zeinab M Omar, Student, Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- laser_ultrasonic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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