Pigmentation Clinical Trial
Official title:
Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation: Randomised Clinical Trial
Verified date | March 2022 |
Source | Okan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main aim of this paper is to explore the efficiancy on the extention and density of pigmentation between diode and Er,Cr:YSGG lasers. The second aim of this study was to investigate the lasers effects of patient pain and comfort.
Status | Completed |
Enrollment | 22 |
Est. completion date | March 10, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Patients with systemic healthy or not taking any medication - Patients who are not pregnant or breastfeeding - Patients between 18-40 years old - Physiologic gingival hyperpigmentation on the facial aspect of maxillary first right premolar to first left premolar region - Patients with esthetic concerns - Patients who have smoked at least 10 cigarettes per day for at least 5 years - Periodontally healthy patients Exclusion Criteria: - Patients with any systemic diseases or taking any medication - Pregnant and lactating women - Patients under 18 years - Patients without gingival melanin pigmentation on the facial aspect of maxillary first right premolar to first left premolar region - Patients who smoke less than 5 years and/or less than 10 cigarettes per day - Non-smokers - Patients with any metallic restoration or undergoing orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Okan University | Istanbul | Tuzla |
Lead Sponsor | Collaborator |
---|---|
Okan University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | depigmentation with two different laser devices | Dummett Oral Pigmentasyon Indeks (DOPI) tehat identifies pigmentation as score 1- no clinical pigmentation (pink tissue), score 2-mild clinical pigmentation (light brown), score 3-moderate clinical pigmentation (mixed brown and pink), and score 4-heavy clinical pigmentation (deep brown to bluish black).
Photographic Image Assesment: All photographs were taken in a standardized environment by using a Canon EOS 700D with Macro Lens EF 100 mm with automatic focusing. All photographs were taken at a standard distance which was 30 cm as recorded from the patient's cental teeth to the edge of the camera lens. The periodontal probe was used for the calibration of intraoral photographs. Photographs were analyzed with ImageJ Software version10.2. The pigmented areas on the photograph will be calculated in mm2. |
1 year | |
Secondary | Pain Perception | The visual analog scale (VAS) was used at intraoperatively, 1st day and 1st week post-operative visits to measure the intensity of pain experienced during and after the treatment. The patients were asked to rate the degree of pain, on a 10 cm horizontal VAS by placing a vertical mark to assess position between the two end-points (from no-pain to severe-pain). | 1 year | |
Secondary | Patient Esthetic Satisfaction | Another VAS was used in the 12th month for evaluation of patient esthetic satisfaction. The patients were asked to rate the degree of esthetic satisfaction, on a 10 cm horizontal VAS by placing a vertical mark to assess position between the two end-points (from not at all to very satisfied). | 1 year |
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