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

NCT04217434 | Unknown

• 1 other identifier: 02_D012_91556
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Healing Surgical Wounds; Analgesia; Temperature Change, Body

Outcome Measures

Primary Outcomes (17)

• 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.

  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

Secondary Outcomes (3)

• ease of cutting

  Baseline

• duration of operation

  intraoperative

• presence/ absence of carbonization

  Baseline

Study Arms (4)

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.

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.

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.

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.

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

Interventions

400 µm fibre length will be used in continuous contact mode PROCEDURE

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.

Group 400µm in continous contact mode

400 µm fibre length will be used in pulsed contact mode PROCEDURE

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.

Group 400µm in pulsed contact mode

300 µm fibre length will be used in continuous mode PROCEDURE

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.

Group 300µm in continous contact mode

300 µm fibre length will be used in pulsed contact mode PROCEDURE

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.

Group 300µm in pulsed contact mode

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Body Temperature Changes

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Dr Hafsa Shereen, MDS

  Rajiv Gandhi University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Dr Kishore H C, MDS

  Rajiv Gandhi University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: January 3, 2020
• Study Start: November 20, 2018
• Primary Completion: March 21, 2020
• Study Completion: November 22, 2020
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)