Postoperative Pain
Conditions
Keywords
endodontic treatment, mandibular molar teeth, apical periodontitis.
Brief summary
The purpose of this study is to evaluate the effects of photobiomodulation (PBM) on postoperative pain after endodontic treatment in mandibular molar teeth diagnosed with symptomatic apical periodontitis.
Interventions
DEVICEPBM 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 .
DEVICEPBM Sham
For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Posterior mandibular molars * No previous root canal therapy on the tooth in question * Able to complete the endodontic treatment in one visit
Exclusion criteria
* Maxillary teeth, mandibular anteriors and premolars * Infection (swelling, sinus tract) on the tooth in question * Periodontal disease on the tooth in question * Dental trauma * Crown/ root fractures * Systemic diseases * Immunocompromised patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by the Visual Analog Scale | 72 hours after treatment | This scale ranges form 0(no pain) to 10(worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by the Visual Analog Scale | 0 hours, 6 hours, 12 hours and 24 hours hours after treatment | This scale ranges form 0(no pain) to 10(worst pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 . | 17 |
| PBM Sham PBM Sham: For the PBM sham similar procedure as PBM therapy will be performed without activating the laser. | 15 |
| Total | 32 |
Baseline characteristics
| Characteristic | PBM Sham | Total | PBM Therapy |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 14.6 | 41.6 years STANDARD_DEVIATION 13.9 | 45.05 years STANDARD_DEVIATION 12.83 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 participants | 32 participants | 17 participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 0 / 17 | 0 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 15 |
Outcome results
Primary
Pain as Assessed by the Visual Analog Scale
This scale ranges form 0(no pain) to 10(worst pain)
Time frame: 72 hours after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PBM Therapy | Pain as Assessed by the Visual Analog Scale | 0 score on a scale | Standard Deviation 0 |
| PBM Sham | Pain as Assessed by the Visual Analog Scale | .33 score on a scale | Standard Deviation 0.48 |
Secondary
Pain as Assessed by the Visual Analog Scale
This scale ranges form 0(no pain) to 10(worst pain)
Time frame: 0 hours, 6 hours, 12 hours and 24 hours hours after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PBM Therapy | Pain as Assessed by the Visual Analog Scale | 0 hours after treatment | 3.94 score on a scale | Standard Deviation 2.01 |
| PBM Therapy | Pain as Assessed by the Visual Analog Scale | 6 hours after treatment | 1.94 score on a scale | Standard Deviation 2.46 |
| PBM Therapy | Pain as Assessed by the Visual Analog Scale | 12 hours after treatment | 0.76 score on a scale | Standard Deviation 0.9 |
| PBM Therapy | Pain as Assessed by the Visual Analog Scale | 24 hours after treatment | 0.23 score on a scale | Standard Deviation 0.43 |
| PBM Sham | Pain as Assessed by the Visual Analog Scale | 24 hours after treatment | 1.4 score on a scale | Standard Deviation 1.18 |
| PBM Sham | Pain as Assessed by the Visual Analog Scale | 0 hours after treatment | 6.13 score on a scale | Standard Deviation 2.5 |
| PBM Sham | Pain as Assessed by the Visual Analog Scale | 12 hours after treatment | 3.33 score on a scale | Standard Deviation 2.4 |
| PBM Sham | Pain as Assessed by the Visual Analog Scale | 6 hours after treatment | 3.86 score on a scale | Standard Deviation 2.7 |