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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03711357
• Other study ID #: Eman Elezaby
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: June 2020

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Radiation:
• 980 nm diode laser
980 nm high power diode laser device.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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