Back to results

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

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

980 nm diode laser

placebo

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

laser

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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".

number of analgesic tablets

the participant will determine the number of analgesic tablets needed to relieve his pain after endodontic retreatment procedures.

Full Information

NCT ID

NCT03711357

First Posted

October 13, 2018

Last Updated

October 16, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03711357

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2018 (Anticipated)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A trial with two parallel groups

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

laser

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

980 nm diode laser

Intervention Description

980 nm high power diode laser device.

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

postoperative pain, measured using Visual analogue scale (VAS)

Description

Time Frame

7 days after root canal re-treatment procedures

Secondary Outcome Measure Information:

Title

Root canal disinfection

Description

Time Frame

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).

Title

number of analgesic tablets

Description

the participant will determine the number of analgesic tablets needed to relieve his pain after endodontic retreatment procedures.

Time Frame

At day 7 after endodontic retreatment procedures

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make the participants data available to other researchers

Learn more about this trial

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

We'll reach out to this number within 24 hrs