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Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial (LASER)

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ClinicalTrials.gov Identifier: NCT04217434
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Healing Surgical Wounds Analgesia Temperature Change, Body Procedure: 400 µm fibre length will be used in continuous contact mode Procedure: 400 µm fibre length will be used in pulsed contact mode Procedure: 300 µm fibre length will be used in continuous mode Procedure: 300 µm fibre length will be used in pulsed contact mode Not Applicable

Detailed Description:

The colour of gingiva has a tremendous impact on the esthetics of the smile. Clinically gingival melanin hyperpigmentation is presented as 'black gum' which is common esthetic problem especially for those who have gummy smile. Currently the growing aesthetic concerns among the patients require the removal of hyper pigmented gingival areas to create an aesthetically-pleasant smile. The harmony of the smile is determined not only by the shape, position and colour of the teeth or lips as well as by the by the gingival tissues.Several attempts have been made for removal of gingival pigmentation by different techniques like scalpel, electrocautery, LASER etc. Each technique has its own advantages and disadvantages. In the present study an effort has been made to compare two different modes viz. Continuous mode and Pulsed mode of LASER in the treatment of depigmentation.Diode LASERs for dentistry operate in the near infrared region. The most commonly used wavelengths are 810, 940 and 980 nm , because these wavelengths are very well absorbed by pigmented tissues, haemoglobin and melanin.There are several different ways LASER light operates: Continuous wave (CW), Pulse wave mode (PM). The continuous wave diodes emit continuous LASER energy with a fixed power output for the entire duration. Pulse modulated diodes create a 'pulse' by cutting the beam or turning LASER on & off [1s] at regular intervals.

During the first years of diode LASER treatment in dentistry only CW mode was possible but application of 3-4 Watt in CW mode led to carbonization of the soft tissue.To approach better results in soft tissue treatment without much carbonization it was necessary to interrupt the CW mode. That was done by chopping the CW mode. Pulses down to several 100μs were released.LASER in Continuous wave mode is suggested in some studies to cause increase in surgical site temperature which may cause necrosis or jeopardize healing. Application of the LASER in Pulsed mode prevents overheating of surrounding tissues. This study aims to determine the comparative increase in the onsite temperature between the two modes.Decrease in post-operative pain is likely to reduce the consumption of Non-steroidal Anti-inflammatory Drugs (NSAID's). The study aims to quantify the need for NSAID's post-operatively in both Pulsed and continuous wave modes and also in 300µ and 400µ fibers.

The change in the diameter of the fibers used in LASER irradiation could bring about a change in the outcome of the procedure as small diameter fibers means high energy density, faster cutting and more heat whereas with larger diameter fibers more energy is needed to cover a broader area to work more quickly and less heat.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : March 21, 2020
Estimated Study Completion Date : November 22, 2020

Arm Intervention/treatment
Experimental: Group 300µm in continous contact mode

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.

Procedure: 300 µm fibre length will be used in continuous mode

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.


Experimental: Group 300µm in pulsed contact mode

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.

Procedure: 300 µm fibre length will be used in pulsed contact mode

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.


Experimental: Group 400µm in continous contact mode

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.

Procedure: 400 µm fibre length will be used in continuous contact mode

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.


Experimental: Group 400µm in pulsed contact mode

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.

Procedure: 400 µm fibre length will be used in pulsed contact mode

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.





Primary Outcome Measures :
  1. pain assessing [ Time Frame: 1st day post operatively. ]
    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.

  2. pain assessing [ Time Frame: 3rd day post operatively. ]
    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.

  3. pain assessing [ Time Frame: 7th day post operatively. ]
    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.

  4. pain assessing [ Time Frame: 14th day post operatively. ]
    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.

  5. pain assessing [ Time Frame: 1 month post operatively. ]
    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.

  6. Healing of gingiva [ Time Frame: 1st day post operatively ]
    hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.

  7. Healing of gingiva [ Time Frame: 3rd day post operatively ]
    hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.

  8. Healing of gingiva [ Time Frame: 7th day post operatively ]
    hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.

  9. Healing of gingiva [ Time Frame: 14th day post operatively ]
    hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.

  10. Healing of gingiva [ Time Frame: 1 month post operatively ]
    hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.

  11. epithelial healing [ Time Frame: 7th day post operatively ]
    3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.

  12. epithelial healing [ Time Frame: 14th day post operatively ]
    3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.

  13. epithelial healing [ Time Frame: 1 month post operatively ]
    3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.

  14. need of analgesics [ Time Frame: 1st day post operatively ]
    on scale of 0-9, where higher variable represents more pain

  15. need of analgesics [ Time Frame: 2nd day post operatively ]
    on scale of 0-9, where higher variable represents more pain

  16. need of analgesics [ Time Frame: 3rd day post operatively ]
    on scale of 0-9, where higher variable represents more pain

  17. rise in temperature [ Time Frame: baseline ]
    FLUKETM 59 Mini (IR) infrared thermometer is used to measure temperature at surgical site, more rise in temperature indicate more carbanoization.


Secondary Outcome Measures :
  1. ease of cutting [ Time Frame: Baseline ]
    on scale on 1-3, more value represents better cutting.

  2. duration of operation [ Time Frame: intraoperative ]
    time duration taken for completing surgical procedure in minutes

  3. presence/ absence of carbonization [ Time Frame: Baseline ]
    on scale of 0-3, higher value indicates more carbonization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Presence of melanin hyper pigmentation of the anterior labial gingival segment
  2. Systemically healthy patients who desires correction of gingival pigmentation
  3. Patients with healthy periodontium
  4. Patients in age group of 18-45 years old

Exclusion Criteria:

  1. Presence of uncontrolled systemic diseases example uncontrolled Diabetes, Hypertension etc.
  2. Pregnant and lactating women
  3. Gingival enlargement
  4. Patients who are on Non-steroidal Anti-inflammatory Drugs (NSAID's) or who have taken antibiotics for last 6 months
  5. Patients who are on drugs that could possibly affect gingival status like phenytoin
  6. Patients who have undergone any form of oral surgery in last 6 months
  7. Asthma patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217434


Locations
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India
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, India, 562157
Sponsors and Collaborators
Krishnadevaraya College of Dental Sciences & Hospital
Investigators
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Principal Investigator: Dr Hafsa Shereen, MDS Rajiv Gandhi University of Health Sciences
Study Director: Dr Kishore H C, MDS Rajiv Gandhi University of Health Sciences
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Responsible Party: Dr Prabhuji MLV, Head of the Department, Krishnadevaraya College of Dental Sciences & Hospital
ClinicalTrials.gov Identifier: NCT04217434    
Other Study ID Numbers: 02_D012_91556
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Body Temperature Changes
Surgical Wound
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries