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

NCT ID: NCT03711357

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A trial with two parallel groups
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
All the participants will be blinded, as they will not know which interventional group they belong to

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

980 nm diode laser

Intervention Type RADIATION

980 nm high power diode laser device.

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

980 nm diode laser

980 nm high power diode laser device.

Intervention Type RADIATION

placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eman Nabil El-Ezaby

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eman Elezaby

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.