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

NCT03711357 | Unknown DMC

• 1 other identifier: Eman Elezaby
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Root canal disinfection

  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

  At day 7 after endodontic retreatment procedures

Study Arms (2)

laser

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

After chemo-mechanical preparation procedures, the diode laser fiber optic tip will be inserted inside the root canals but not activated.

Other: placebo

Interventions

980 nm diode laser RADIATION

980 nm high power diode laser device.

laser

placebo OTHER

the diode laser fiber optic tip will be inserted in root canals, but will not be activated.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All the participants will be blinded, as they will not know which interventional group they belong to
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A trial with two parallel groups

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 18, 2018
• Study Start: October 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share