Clinical trial NCT03711357: Effect of 980nm Diode Laser on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A trial with two parallel groups
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative pain, measured using Visual analogue scale (VAS)
timeFrame: 7 days after root canal re-treatment procedures
Secondary outcomes:
measure: Root canal disinfection
timeFrame: 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).
measure: number of analgesic tablets
timeFrame: At day 7 after endodontic retreatment procedures
Other outcomes:
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