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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)

Primary Purpose

Pain, Postoperative, Healing Surgical Wounds, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
400 µm fibre length will be used in continuous contact mode
400 µm fibre length will be used in pulsed contact mode
300 µm fibre length will be used in continuous mode
300 µm fibre length will be used in pulsed contact mode
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Krishnadevaraya college of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 300µm in continous contact mode

Group 300µm in pulsed contact mode

Group 400µm in continous contact mode

Group 400µm in pulsed contact mode

Arm Description

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 , 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
need of analgesics
on scale of 0-9, where higher variable represents more pain
need of analgesics
on scale of 0-9, where higher variable represents more pain
need of analgesics
on scale of 0-9, where higher variable represents more pain
rise in temperature
FLUKETM 59 Mini (IR) infrared thermometer is used to measure temperature at surgical site, more rise in temperature indicate more carbanoization.

Secondary Outcome Measures

ease of cutting
on scale on 1-3, more value represents better cutting.
duration of operation
time duration taken for completing surgical procedure in minutes
presence/ absence of carbonization
on scale of 0-3, higher value indicates more carbonization

Full Information

First Posted
December 12, 2019
Last Updated
January 2, 2020
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04217434
Brief Title
Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
Acronym
LASER
Official Title
A Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
March 21, 2020 (Anticipated)
Study Completion Date
November 22, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Healing Surgical Wounds, Analgesia, Temperature Change, Body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 300µm in continous contact mode
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 300µm in pulsed contact mode
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 400µm in continous contact mode
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 400µm in pulsed contact mode
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
400 µm fibre length will be used in continuous contact mode
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
400 µm fibre length will be used in pulsed contact mode
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
300 µm fibre length will be used in continuous mode
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
300 µm fibre length will be used in pulsed contact mode
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain assessing
Description
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.
Time Frame
1st day post operatively.
Title
pain assessing
Description
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.
Time Frame
3rd day post operatively.
Title
pain assessing
Description
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.
Time Frame
7th day post operatively.
Title
pain assessing
Description
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.
Time Frame
14th day post operatively.
Title
pain assessing
Description
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.
Time Frame
1 month post operatively.
Title
Healing of gingiva
Description
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Time Frame
1st day post operatively
Title
Healing of gingiva
Description
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Time Frame
3rd day post operatively
Title
Healing of gingiva
Description
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Time Frame
7th day post operatively
Title
Healing of gingiva
Description
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Time Frame
14th day post operatively
Title
Healing of gingiva
Description
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Time Frame
1 month post operatively
Title
epithelial healing
Description
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
Time Frame
7th day post operatively
Title
epithelial healing
Description
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
Time Frame
14th day post operatively
Title
epithelial healing
Description
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
Time Frame
1 month post operatively
Title
need of analgesics
Description
on scale of 0-9, where higher variable represents more pain
Time Frame
1st day post operatively
Title
need of analgesics
Description
on scale of 0-9, where higher variable represents more pain
Time Frame
2nd day post operatively
Title
need of analgesics
Description
on scale of 0-9, where higher variable represents more pain
Time Frame
3rd day post operatively
Title
rise in temperature
Description
FLUKETM 59 Mini (IR) infrared thermometer is used to measure temperature at surgical site, more rise in temperature indicate more carbanoization.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
ease of cutting
Description
on scale on 1-3, more value represents better cutting.
Time Frame
Baseline
Title
duration of operation
Description
time duration taken for completing surgical procedure in minutes
Time Frame
intraoperative
Title
presence/ absence of carbonization
Description
on scale of 0-3, higher value indicates more carbonization
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of melanin hyper pigmentation of the anterior labial gingival segment Systemically healthy patients who desires correction of gingival pigmentation Patients with healthy periodontium Patients in age group of 18-45 years old Exclusion Criteria: Presence of uncontrolled systemic diseases example uncontrolled Diabetes, Hypertension etc. Pregnant and lactating women Gingival enlargement Patients who are on Non-steroidal Anti-inflammatory Drugs (NSAID's) or who have taken antibiotics for last 6 months Patients who are on drugs that could possibly affect gingival status like phenytoin Patients who have undergone any form of oral surgery in last 6 months Asthma patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Hafsa Shereen, MDS
Organizational Affiliation
Rajiv Gandhi University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Kishore H C, MDS
Organizational Affiliation
Rajiv Gandhi University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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

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