Clinical trial NCT04217434: Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
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
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Healing Surgical Wounds
Analgesia
Temperature Change, Body
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: pain assessing
timeFrame: 1st day post operatively.
measure: pain assessing
timeFrame: 3rd day post operatively.
measure: pain assessing
timeFrame: 7th day post operatively.
measure: pain assessing
timeFrame: 14th day post operatively.
measure: pain assessing
timeFrame: 1 month post operatively.
measure: Healing of gingiva
timeFrame: 1st day post operatively
measure: Healing of gingiva
timeFrame: 3rd day post operatively
measure: Healing of gingiva
timeFrame: 7th day post operatively
measure: Healing of gingiva
timeFrame: 14th day post operatively
measure: Healing of gingiva
timeFrame: 1 month post operatively
measure: epithelial healing
timeFrame: 7th day post operatively
measure: epithelial healing
timeFrame: 14th day post operatively
measure: epithelial healing
timeFrame: 1 month post operatively
measure: need of analgesics
timeFrame: 1st day post operatively
measure: need of analgesics
timeFrame: 2nd day post operatively
measure: need of analgesics
timeFrame: 3rd day post operatively
measure: rise in temperature
timeFrame: baseline
Secondary outcomes:
measure: ease of cutting
timeFrame: Baseline
measure: duration of operation
timeFrame: intraoperative
measure: presence/ absence of carbonization
timeFrame: Baseline
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Rajiv Gandhi University of Health Sciences
name: Dr Hafsa Shereen, MDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajiv Gandhi University of Health Sciences
name: Dr Kishore H C, MDS
role: STUDY_DIRECTOR
References: