Clinical trial NCT05304624: Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation
Official title: Comparison of Er,Cr:YSGG Laser and Diode Laser in the Treatment of Gingival Melanin Pigmentation: Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pigmentation
Keywords: Er,Cr:YSGG laser
Diode Laser
Gingival pigmentation
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: depigmentation with two different laser devices
timeFrame: 1 year
Secondary outcomes:
measure: Pain Perception
timeFrame: 1 year
measure: Patient Esthetic Satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
state: Tuzla
Study officials:
affiliation: Istanbul Okan University, Istanbul
name: Ekin Beşiroğlu
role: PRINCIPAL_INVESTIGATOR
References: