NCT03015987

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

January 4, 2017

Last Update Submit

January 10, 2017

Conditions

Keywords

Diode laserasymptomatic pulpLaser activated irrigationcontinuous ultrasonic activationpost obturation pain

Outcome Measures

Primary Outcomes (1)

  • post operative pain

    intensity of post operative pain will be measured using a numerical rating (NRS)scale

    up to 1 week

Study Arms (2)

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.

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.

Other: diode laser activated irrigation

Interventions

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

Also known as: diode laser
diode laser activated irrigationultrasonic activated irrigation

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Necrosis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Ghada A Eid, Professor

    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

    STUDY CHAIR
  • Hanaa M El shinawy, Researcher professor

    Surgery &oral medicine department -National Research Institute-Cairo University

    STUDY DIRECTOR
  • Zeinab M Omar, Student

    Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeinab M Omar, student

CONTACT

Ghada A Eid, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 10, 2017

Study Start

February 1, 2017

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

January 11, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share