Effect of 980nm Diode Laser on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases

Evaluation of the Effect of 980nm Diode Laser Intracanal Irradiation on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases With Chronic Periapical Lesions

A randomized clinical trial that evaluates the effect of using 980nm diode laser intracanal irradiation on postoperative pain and root canal disinfection in endodontic retreatment cases with chronic periapical lesions

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Radiation: 980 nm diode laser; Other: placebo

Detailed Description

The endodontic retreatment procedures will be carried out for the participants, then 980nm Diode laser will be used to disinfect root canals. The researcher will then take microbiological samples of the root canals, to determine count and type of microorganisms in root canals. The subject will be asked to determine his level of pain at 7 days after endodontic retreatment procedures in a visual analogue scale (VAS), and to determine number of analgesic tablets needed to relieve his pain in the given charts. The subject will then return to the clinic 7 days later to bring back his charts. The researcher then will take another microbiological sample of the root canals, and complete the endodontic retreatment procedures.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Endodontic retreatment cases of single rooted teeth with chronic periapical lesions; with periapical radiolucency of less than 1 cm diameter will be selected.
2. Teeth with straight root canals.
3. Subjects aged between 18-50 years of age.
4. No contributory medical history.
5. No previous administration of analgesics and / or antibiotics within the previous 2 weeks.

Exclusion Criteria:

1. Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
2. Teeth with curved roots.
3. Swelling or sinus tract.
4. Mutilated teeth that interfere with proper isolation and seal between visits.
5. Subjects with generalized periodontitis, or if the tooth has probing depth of more than 3 mm.
6. Subjects with uncontrolled diabetes or debilitating diseases.
7. Pregnant or nursing females.
8. Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laser; 980 nm diode laser (maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter) will be used for four irradiations, of 5 seconds each, after chemo-mechanical preparation procedures.	Radiation: 980 nm diode laser; 980 nm high power diode laser device.
Placebo Comparator: Placebo; After chemo-mechanical preparation procedures, the diode laser fiber optic tip will be inserted inside the root canals but not activated.	Other: placebo; the diode laser fiber optic tip will be inserted in root canals, but will not be activated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain, measured using Visual analogue scale (VAS)	Visual analogue scale (VAS) will be used for to record severity of pain. It is a (0-10) scale. Criteria to determine the severity of postoperative pain will be as follows: (0: no pain), (1-3: mild pain), (4-6: moderate pain), (7-10: severe pain).	7 days after root canal re-treatment procedures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root canal disinfection	Number of microorganisms found in root canals will be determined using "Bacterial culture";"Initial sample", 'Pre-lasing sample, "Post-lasing". and "Recolonization sample", in the "Laser group" and "Placebo group".	Four samples will be taken; first, second and third samples will be taken at first visit of endodontic retreatment procedures. while, the fourth sample will be taken in the second visit (7 days later).
number of analgesic tablets	the participant will determine the number of analgesic tablets needed to relieve his pain after endodontic retreatment procedures.	At day 7 after endodontic retreatment procedures

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: October 13, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Eman Elezaby

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make the participants data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No