LASER
A Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
Sponsor study identifier
interventional
40
1 country
1
Study Start
November 20, 2018
Actual (reported)Primary Completion
March 21, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 22, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Purpose of this study is to clinically evaluate and compare various patient centered outcomes using diode LASER in Continuous mode (CW) and Pulsed Mode (PM) using 300µm and 400µm fiber for depigmentation procedure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 20, 2018
Actual (reported)December 12, 2019
Actual (reported)January 3, 2020
Actual (reported)March 21, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 22, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
pain assessing
visual analogue scale (VAS) method - a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcomes.
1st day post operatively.
pain assessing
visual analogue scale (VAS) method - a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcomes.
3rd day post operatively.
pain assessing
visual analogue scale (VAS) method - a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcomes.
7th day post operatively.
pain assessing
visual analogue scale (VAS) method - a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcomes.
ease of cutting
Baseline
duration of operation
intraoperative
presence/ absence of carbonization
Baseline
Diode LASER (A.R.C Fox , Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline.LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes , 300 µm fibre length will be used in continuous contact mode at a power setting of 1.5 to 3 W. • Simultaneously, increase in temperature on site will be recorded using FLUKETM 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain. Post operative instructions will be given.
Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline\].LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes, 300 µm fibre length will be used in pulsed contact mode at a power setting of 1.5 - 3 W. Simultaneously, increase in temperature on site will be recorded using FLUKETM 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain. Post operative instructions will be given.
Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline\]. LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 400 µm fibre length will be used in continuous contact mode at a power setting of 1.5 - 3W. Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given.
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157, India
Dr Hafsa Shereen, MDS
Rajiv Gandhi University of Health Sciences
Dr Kishore H C, MDS
Rajiv Gandhi University of Health Sciences
First Submitted
December 12, 2019
First Posted
January 3, 2020
Study Start
November 20, 2018
Actual (reported)Primary Completion
March 21, 2020
Estimated (date passed)14th day post operatively.
pain assessing
visual analogue scale (VAS) method - a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcomes.
1 month post operatively.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
1st day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
3rd day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
7th day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
14th day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
1 month post operatively
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
7th day post operatively
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
14th day post operatively
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
1 month post operatively
need of analgesics
on scale of 0-9, where higher variable represents more pain
1st day post operatively
need of analgesics
on scale of 0-9, where higher variable represents more pain
2nd day post operatively
need of analgesics
on scale of 0-9, where higher variable represents more pain
3rd day post operatively
rise in temperature
FLUKETM 59 Mini (IR) infrared thermometer is used to measure temperature at surgical site, more rise in temperature indicate more carbanoization.
baseline
Diode LASER (A.R.C Fox , Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline.LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes , 400 µm fibre length will be used in continuous contact mode at a power setting of 1.5 - 3 W. • Simultaneously, increase in temperature on site will be recorded using FLUKETM 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain. Post operative instructions will be given.
Diode LASER (A.R.C Fox , Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline.LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes , 400 µm fibre length will be used in pulsed contact mode at a power setting of 1.5 t 3 W. • Simultaneously, increase in temperature on site will be recorded using FLUKETM 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain. Post operative instructions will be given.
Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline\]. LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 400µm fibre length will be used pulsed contact mode at a power setting of 1.5 - 3W. Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given.
Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline\]. LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 300 µm fibre length will be used continous contact mode at a power setting of 1.5 - 3W. Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given.
Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses. Local infiltration is administered with Lignox®\[ 2% lignocaine in 1:80000 adrenaline\]. LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 300 µm fibre length will be used pulsed contact mode at a power setting of 1.5 - 3W. .Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 22, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 3, 2020
Record last verified: 2020-01
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