Trial Outcomes & Findings for Effects of Photobiomodulation on Postoperative Pain After Primary Endodontic Therapy in Molars With Symptomatic Apical Periodontitis (NCT NCT05032612)

Results Overview

This scale ranges form 0(no pain) to 10(worst pain)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

72 hours after treatment

Results posted on

2023-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	PBM Therapy PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .	PBM Sham PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.
Overall Study STARTED	17	15
Overall Study COMPLETED	17	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PBM Therapy n=17 Participants PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .	PBM Sham n=15 Participants PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.	Total n=32 Participants Total of all reporting groups
Age, Continuous	45.05 years STANDARD_DEVIATION 12.83 • n=17 Participants	37.7 years STANDARD_DEVIATION 14.6 • n=15 Participants	41.6 years STANDARD_DEVIATION 13.9 • n=32 Participants
Sex: Female, Male Female	11 Participants n=17 Participants	12 Participants n=15 Participants	23 Participants n=32 Participants
Sex: Female, Male Male	6 Participants n=17 Participants	3 Participants n=15 Participants	9 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	15 participants n=15 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: 72 hours after treatment

This scale ranges form 0(no pain) to 10(worst pain)

Outcome measures

Outcome measures
Measure	PBM Therapy n=17 Participants PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .	PBM Sham n=15 Participants PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.
Pain as Assessed by the Visual Analog Scale	0 score on a scale Standard Deviation 0	.33 score on a scale Standard Deviation .48

SECONDARY outcome

Timeframe: 0 hours, 6 hours, 12 hours and 24 hours hours after treatment

This scale ranges form 0(no pain) to 10(worst pain)

Outcome measures

Outcome measures
Measure	PBM Therapy n=17 Participants PBM Therapy: After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .	PBM Sham n=15 Participants PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.
Pain as Assessed by the Visual Analog Scale 0 hours after treatment	3.94 score on a scale Standard Deviation 2.01	6.13 score on a scale Standard Deviation 2.5
Pain as Assessed by the Visual Analog Scale 6 hours after treatment	1.94 score on a scale Standard Deviation 2.46	3.86 score on a scale Standard Deviation 2.7
Pain as Assessed by the Visual Analog Scale 12 hours after treatment	0.76 score on a scale Standard Deviation 0.90	3.33 score on a scale Standard Deviation 2.4
Pain as Assessed by the Visual Analog Scale 24 hours after treatment	0.23 score on a scale Standard Deviation 0.43	1.4 score on a scale Standard Deviation 1.18

Adverse Events

PBM Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PBM Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Kirkpatrick, DDS

The University of Texas Health Science Center at Houston

Phone: 713-486-4227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place