Clinical trial NCT04680806: Laser-Assisted Gingival Depigmentation
Official title: Gingival Depigmentation With Er,Cr:YSGG and Diode Laser: Randomized Clinical Trial to Evaluate the Repigmentation and Patient Perceptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperpigmentation; Melanin
Laser-Induced Hyperpigmentation
Keywords: Depigmentation
Gingival Hyperpigmentation
Diode laser
Er,Cr:YSGG laser
Repigmentation
Lead sponsor: Academy of Laser Dentistry - Gulf Laser Chapter
Sponsor class: OTHER
Collaborators: name: Damascus University
First posted: 2020-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly allocated to the two treatment groups: -Group A was treated by an Er,Cr:YSGG laser 2780 nm.

-Group B: was treated with diode 940 nm Laser.
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.

Detailed description: This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.

The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.

Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.

All of the patients were selected according to the study inclusion and exclusion criteria.

Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.

The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.

Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.

The patients who did not show in all the study follow up's appointments were dropped from the data analysis.

Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.

Eligibility criteria: Inclusion Criteria:

• All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)

Exclusion Criteria:

* Pathologic hyperpigmentation
* Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
* Pregnancy and lactation
* History of smoking
* Previous mucogingival surgery at the region to be treated
* No contraindication for the laser treatment.

Primary outcomes:
measure: Oral pigmentation index (DOPI)
timeFrame: Baseline
measure: Oral pigmentation index (DOPI)
timeFrame: 1 month post-operative
measure: Oral pigmentation index (DOPI)
timeFrame: 1 year follow-up
measure: Oral pigmentation index (DOPI)
timeFrame: 2 years follow-up
measure: Melanin pigmentation index:
timeFrame: Baseline
measure: Melanin pigmentation index:
timeFrame: 1 month post-operative
measure: Melanin pigmentation index:
timeFrame: 1 year follow-up
measure: Melanin pigmentation index:
timeFrame: 2 years follow-up
measure: Gingival Appearance
timeFrame: 1 month
Secondary outcomes:
measure: Oral Hygiene Index
timeFrame: Baseline
measure: Oral Hygiene Index
timeFrame: 1 month post-operative
measure: Gingival Index
timeFrame: Baseline
measure: Gingival Index
timeFrame: 1 month post-operative
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Dr. Tamim Dental Polyclinic
Study officials:
affiliation: Damascus University
name: Omar Hamadah, PhD
role: STUDY_DIRECTOR
References:
citation: Simsek Kaya G, Yapici Yavuz G, Sumbullu MA, Dayi E. A comparison of diode laser and Er:YAG lasers in the treatment of gingival melanin pigmentation. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Mar;113(3):293-9. doi: 10.1016/j.tripleo.2011.03.005. Epub 2011 Jun 12.
citation: Nammour S, El Mobadder M, Namour M, Namour A, Rompen E, Maalouf E, Brugnera Junior A, Brugnera AP, Vescovi P, Zeinoun T. A Randomized Comparative Clinical Study to Evaluate the Longevity of Esthetic Results of Gingival Melanin Depigmentation Treatment Using Different Laser Wavelengths (Diode, CO2, and Er:YAG). Photobiomodul Photomed Laser Surg. 2020 Mar;38(3):167-173. doi: 10.1089/photob.2019.4672. Epub 2020 Jan 17.
citation: Hegde R, Padhye A, Sumanth S, Jain AS, Thukral N. Comparison of surgical stripping; erbium-doped:yttrium, aluminum, and garnet laser; and carbon dioxide laser techniques for gingival depigmentation: a clinical and histologic study. J Periodontol. 2013 Jun;84(6):738-48. doi: 10.1902/jop.2012.120094. Epub 2012 Sep 24.