Pain, Postoperative Clinical Trial
— LASEROfficial title:
A Comparative Evaluation of Various Patient Centered Outcomes Following Gingival Depigmentation Using Diode LASER in Different Modes: A Randomized Clinical Trial
Verified date | January 2020 |
Source | Krishnadevaraya College of Dental Sciences & Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | November 22, 2020 |
Est. primary completion date | March 21, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
India | Krishnadevaraya college of dental sciences | Bangalore | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Krishnadevaraya College of Dental Sciences & Hospital |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Healing of gingiva | hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes. | 1st day post operatively | |
Primary | Healing of gingiva | hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes. | 3rd day post operatively | |
Primary | Healing of gingiva | hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes. | 7th day post operatively | |
Primary | Healing of gingiva | hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes. | 14th day post operatively | |
Primary | Healing of gingiva | hick healing index- score ranges from 0 to 4, higher values indicate the worst outcomes. | 1 month post operatively | |
Primary | epithelial healing | 3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization. | 7th day post operatively | |
Primary | epithelial healing | 3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization. | 14th day post operatively | |
Primary | epithelial healing | 3% of hydrogen peroxide is applied on the operated area. no bubble- complete epithelization, bubble formation- incomplete epithelization. | 1 month post operatively | |
Primary | need of analgesics | on scale of 0-9, where higher variable represents more pain | 1st day post operatively | |
Primary | need of analgesics | on scale of 0-9, where higher variable represents more pain | 2nd day post operatively | |
Primary | need of analgesics | on scale of 0-9, where higher variable represents more pain | 3rd day post operatively | |
Primary | 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 | ease of cutting | on scale on 1-3, more value represents better cutting. | Baseline | |
Secondary | duration of operation | time duration taken for completing surgical procedure in minutes | intraoperative | |
Secondary | presence/ absence of carbonization | on scale of 0-3, higher value indicates more carbonization | Baseline |
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