Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation

Pigmentation Clinical Trial

Official title:

Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation: Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304624
• Other study ID #: E-68869993-511
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2022
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Recently, soft tissue aesthetics has become an important issue in dentistry. The normal physiological color of the gingiva is coral pink or pale pink. The color of gingiva is determined by several factors, including thickness of ephitelium, degree of keratinization, the number and size of underlying blood vessels and pigments within the epithelium. Gingival hyperpigmentation is caused by excessive deposition of melanin located in the basal and suprabasal cell layers of the epithelium. Many etiological factors such as smoking can stimulate melanin pigmentation. It has been reported that polycyclic amines such as nicotine and benzopyrene, which are known to penetrate melanocytes and bind to melanin, in cigarettes cause stimulation of melanocytes and as a result increase melanin production. Smoker melanocyte pigmentation was described first time by Hedin in 1977 as 'a local benign melanin pigmentation often seen in the attached gingiva'. Although physiologic melanin pigmentation and smoker melanosis are not medical problems, patients seek treatment for esthetic purposes. Various depigmentation techniques are employed to address the aesthetic concerns of individuals. Methods used for depigmentation: Chemical treatment, electrosurgery, abrasion with diamond tools, scalpel technique, gingivectomy, gingival graft, cryosurgery and lasers. Which method to choose depends on clinical experience and individual preferences. However, most researchers consider laser ablation to be more effective, convenient, and safer for gingival depigmentation. Many laser systems such as CO2 laser, Diyot laser, Neodymium Doped:Yttrium Aluminum Garnet(Nd:YAG) laser, Erbium Doped:Yttrium Aluminum Garnet(Er:YAG) laser and Erbium Chromium-Doped:Yttrium, Scandium, Gallium, Garnet(Er,Cr:YSGG) are used for this purpose. In melanin depigmentation with laser, the ability melanocytes which containing melanin to absorb the laser beam depends on the wavelength and water. The wavelength of the Er,Cr:YSGG laser is 2780nm, while the wavelength of the diode laser is 810-980nm.10 While diode laser is used for soft tissue surgery, Er,Cr:YSGG laser is used for soft and hard tissue surgery. Although there are more case reports regarding the use of diode lasers in gingival depigmentation, only a few focus on the use of Er, Cr:YSGG laser. In this study; in the treatment of gingival depigmentation by use of Er, Cr: YSGG laser and Diode laser to patients, it was aimed to evaluate the satisfaction of the patients during and after the operation, to evaluate the change in gingival tissue thickness and to evaluate the rate of repigmentation.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pigmentation

Intervention

Device:
• laser
these lasers are routinely used in dental practice

Locations

Country	Name	City	State
Turkey	Istanbul Okan University	Istanbul	Tuzla

Sponsors (1)

Lead Sponsor	Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

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