Pain, PostoperativeLASERNCT04217434
Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
A study testing 400 µm fibre length will be used in continuous contact mode, 400 µm fibre length will be used in pulsed contact mode and 300 µm fibre length will be used in continuous mode in people with Pain, Postoperative and Healing Surgical Wounds, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Healing Surgical Wounds, Analgesia
- What is being tested?
- 400 µm fibre length will be used in continuous contact mode, 400 µm fibre length will be used in pulsed contact mode and 300 µm fibre length will be used in continuous mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 20 Nov 2018to 22 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: A Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
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.
Read the 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.
- Being tested
- 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
- Medical subject headings
- Pain, Postoperative, Agnosia, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 µm fibre length will be used in continuous contact modeProcedure or surgery
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.
400 µm fibre length will be used in pulsed contact modeProcedure or surgery
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.
300 µm fibre length will be used in continuous modeProcedure or surgery
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.
300 µm fibre length will be used in pulsed contact modeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 300µm in continous contact mode | Experimental | 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. Receives: Procedure: 300 µm fibre length will be used in continuous mode |
| Group 300µm in pulsed contact mode | Experimental | 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. Receives: Procedure: 300 µm fibre length will be used in pulsed contact mode |
| Group 400µm in continous contact mode | Experimental | 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. Receives: Procedure: 400 µm fibre length will be used in continuous contact mode |
| Group 400µm in pulsed contact mode | Experimental | 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. Receives: Procedure: 400 µm fibre length will be used in pulsed contact mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month post operatively.
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Measured: 1st day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Measured: 3rd day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Measured: 7th day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Measured: 14th day post operatively
Healing of gingiva
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Measured: 1 month post operatively
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
Measured: 7th day post operatively
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
Measured: 14th day post operatively
epithelial healing
3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization.
Measured: 1 month post operatively
need of analgesics
on scale of 0-9, where higher variable represents more pain
Measured: 1st day post operatively
need of analgesics
on scale of 0-9, where higher variable represents more pain
Measured: 2nd day post operatively
need of analgesics
on scale of 0-9, where higher variable represents more pain
Measured: 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.
Measured: baseline
Secondary outcomes (3)
ease of cutting
on scale on 1-3, more value represents better cutting.
Measured: Baseline
duration of operation
time duration taken for completing surgical procedure in minutes
Measured: intraoperative
presence/ absence of carbonization
on scale of 0-3, higher value indicates more carbonization
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start20 Nov 2018
- Primary completion21 Mar 2020 (estimated)
- Study completion22 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
- Investigators
- Dr Hafsa Shereen, MDS, Principal investigator, Rajiv Gandhi University of Health SciencesDr Kishore H C, MDS, Study director, Rajiv Gandhi University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217434
- Sponsor's protocol ID
- 02_D012_91556
- Acronym
- LASER
- Status last verified
- Jan 2020
- First submitted
- 12 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04217434
- Acronym / sponsor ID
- LASER / 02_D012_91556
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 21 Mar 2020 (estimated)
- Study completion
- 22 Nov 2020 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 300µm in continous contact mode | Experimental | Procedure: 300 µm fibre length will be used in continuous modeDiode 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. |
| Group 300µm in pulsed contact mode | Experimental | Procedure: 300 µm fibre length will be used in pulsed contact modeDiode 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. |
| Group 400µm in continous contact mode | Experimental | Procedure: 400 µm fibre length will be used in continuous contact modeDiode 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. |
| Group 400µm in pulsed contact mode | Experimental | Procedure: 400 µm fibre length will be used in pulsed contact modeDiode 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400 µm fibre length will be used in continuous contact modeDiode 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. | Procedure or surgery | Group 400µm in continous contact mode |
| 400 µm fibre length will be used in pulsed contact modeDiode 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. | Procedure or surgery | Group 400µm in pulsed contact mode |
| 300 µm fibre length will be used in continuous modeDiode 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. | Procedure or surgery | Group 300µm in continous contact mode |
| 300 µm fibre length will be used in pulsed contact modeDiode 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. | Procedure or surgery | Group 300µm in pulsed contact mode |
Primary outcome
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.
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.
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.
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.
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.
Healing of gingiva
Time frame: 1st day post operatively
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
Time frame: 3rd day post operatively
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
Time frame: 7th day post operatively
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
Time frame: 14th day post operatively
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
Healing of gingiva
Time frame: 1 month post operatively
hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes.
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.
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.
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.
need of analgesics
Time frame: 1st day post operatively
on scale of 0-9, where higher variable represents more pain
need of analgesics
Time frame: 2nd day post operatively
on scale of 0-9, where higher variable represents more pain
need of analgesics
Time frame: 3rd day post operatively
on scale of 0-9, where higher variable represents more pain
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.
3 secondary outcomes
ease of cutting
Time frame: Baseline
duration of operation
Time frame: intraoperative
presence/ absence of carbonization
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Hafsa Shereen, MDS principal investigator
Rajiv Gandhi University of Health Sciences
Dr Kishore H C, MDS study director
Rajiv Gandhi University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 µm fibre length will be used in continuous contact mode, 400 µm fibre length will be used in pulsed contact mode and 300 µm fibre length will be used in continuous mode in people with Pain, Postoperative and Healing Surgical Wounds, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessing (time frame: 1st day post operatively.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.