]>
IRCT20160408027277N1 IRCT 2018-10-06 Arak University of Medical Sciences Laser therapy and Cryosurgery in the treatment of Gingival Physiologic Hyperpigmentation A Comparison of 940 nm Diode Laser and Cryosurgery with Liquid Nitrogen in the Treatment of Gingival Physiologic Hyperpigmentation using Split Mouth Technique 2015-03-01 anticipated 15 Complete https://irct.ir/trial/28866 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Maxillary gingiva of each patient was split into right and left halves (Split Mouth technique). One half was treated by 940 nm diode laser and the other half by cryosurgery. The divided areas were randomly allotted for depigmentation by coin toss, Blinding description: The study is designed double blinded so that the participants in the study (patients) are unaware of the type of intervention implemented on their gums and the experts reviewing the results of the two interventions are also unaware of the type of intervention done on the patients' gingival sites. In order to achieve the goals of blindness in this study, it needs to be explained that the expert doing the surgical procedure is different from the one evaluating the results of the two surgical procedures and the expert evaluator is completely unaware of the type of surgical method used in the surgical sites and is selected from outside of the surgical team. N/A Physiologic Gingival Hyperpigmentation. Intervention 1: Intervention group 1: 940 nm Diode Laser, EpicTM 10 diode type with wavelength of 940±10 nm, operating maximum power output of 10W, 0.01 ms to 20 s pulse duration, contact continuous mode, with 300 μm fiber tip diameter, spot size 30mm diameter (= 7.1 cm2 area) and manufactured by Biolase Company, USA. Firstly, gingiva received anesthesia with 2% lidocaine and the tip of laser was placed and moved on the entire pigmented area from the mucogingival line towards the free gingival margin, including the papillae until the pigmented area was de-epithelialized and a normal pink color of gingiva was apparent. The carbonized gingiva was wiped with a moist sterile gauze to ensure that no pigmented spots remained. Intervention 2: Intervention group 2: Cryotherapy with liquid Nitrogen, a 10-liter three-chambered tank of liquid nitrogen (-196°C), made in China, was used. Some liquid nitrogen was poured inside a plastic cup and the tip of a cotton swab was dipped in the liquid and placed inside a small finger-like plastic and then placed on the pigmented gingiva for 3 to 5 seconds. Sessions of cryosurgery was repeated until depigmentation was satisfactory. No - There is not a plan to make this available Justification or reason for not sharing IPD is After the publication of this article in a journal if the privacy of patients is not invaded information will be given to the respected center.
public Dr. Mohammad Keivan
Between Andisheh 5 and 6 Alleys, Ghadir Blvd., Nabaei town, Sardasht
Arak Iran (Islamic Republic of) 3848153793 +98 86 3272 4522 keivan57@gmail.com Arak University of Medical Sciences scientific Dr. Mohammad Keivan
Between Andisheh 5 and 6 Alleys, Ghadir Boulevard, Nabaei town
Arak Iran (Islamic Republic of) 3848159345 +98 86 3272 4522 keivan57@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Physiologic Gingival Hyperpigmentaion 17 years 35 years Both Amalgam tattoo Oral melanotic macule Malignant melanoma Drug-induced melanosis Smoker's melanosis Melanosis associated with systemic and genetic diseases Hemochromatosis Graphite tattoo Decorative tattoos Pigmentation due to pharmaceutical and heavy metals Pregnancy-related pigmentation Treatment - Devices Treatment - Devices Intervention group 1: 940 nm Diode Laser, EpicTM 10 diode type with wavelength of 940±10 nm, operating maximum power output of 10W, 0.01 ms to 20 s pulse duration, contact continuous mode, with 300 μm fiber tip diameter, spot size 30mm diameter (= 7.1 cm2 area) and manufactured by Biolase Company, USA. Firstly, gingiva received anesthesia with 2% lidocaine and the tip of laser was placed and moved on the entire pigmented area from the mucogingival line towards the free gingival margin, including the papillae until the pigmented area was de-epithelialized and a normal pink color of gingiva was apparent. The carbonized gingiva was wiped with a moist sterile gauze to ensure that no pigmented spots remained. Intervention group 2: Cryotherapy with liquid Nitrogen, a 10-liter three-chambered tank of liquid nitrogen (-196°C), made in China, was used. Some liquid nitrogen was poured inside a plastic cup and the tip of a cotton swab was dipped in the liquid and placed inside a small finger-like plastic and then placed on the pigmented gingiva for 3 to 5 seconds. Sessions of cryosurgery was repeated until depigmentation was satisfactory. Physiologic Gingival Pigmentation Index. Timepoint: Before treatment, 3, 7, 10, 17, 21 days and 1, 3, 6, 12 months post-operatively. Method of measurement: Observation. Post-operative pain. Timepoint: On the day of treatment. Method of measurement: Questionnaire. Duration of Gingival healing. Timepoint: Before treatment, 3, 7, 10, 14,17 and 21 days post-operatively. Method of measurement: Observation. Pigmentation recurrence. Timepoint: 1, 3, 6, 12 months after the treatment. Method of measurement: Observation. Patient satisfaction. Timepoint: one year after treatment. Method of measurement: questionnaire. Arak University of Medical Sciences Approved 2016-02-20 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij Square, Sardasht, Khalij Fars Boulevard Arak Markazi Iran (Islamic Republic of)