Laser-Assisted Gingival Depigmentation

NCT04680806 | Completed FDA Device

• 1 other identifier: GulfLaserChapter
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation; Melanin; Laser-Induced Hyperpigmentation

Keywords

Depigmentation; Gingival Hyperpigmentation; Diode laser; Er,Cr:YSGG laser; Repigmentation

Outcome Measures

Primary Outcomes (9)

• Oral pigmentation index (DOPI)

  * Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)

  Baseline

• Oral pigmentation index (DOPI)

  * Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)

  1 month post-operative

• Oral pigmentation index (DOPI)

  * Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)

  1 year follow-up

• Oral pigmentation index (DOPI)

  * Score 1: No clinical pigmentation (pink-colored gingiva) * Score 2: Mild clinical pigmentation (mild light brown color) * Score 3: Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Score 4: Heavy clinical pigmentation (deep brown or bluish black color)

  2 years follow-up

• Melanin pigmentation index:

  * Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units

  Baseline

• Melanin pigmentation index:

  * Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units

  1 month post-operative

• Melanin pigmentation index:

  * Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units

  1 year follow-up

• Melanin pigmentation index:

  * Score 0: No pigmentation * Score 1: Solitary unit(s) of pigmentation in papillary gingiva without extension between neighboring solitary units * Score 2: Formation of continuous ribbon extending from neighboring solitary units

  2 years follow-up

• Gingival Appearance

  * Score 1:Pink vital appearance for the gingiva * Score 2: Pale Non-vital appearance for gingiva

  1 month

Secondary Outcomes (4)

• Oral Hygiene Index

  Baseline

• Oral Hygiene Index

  1 month post-operative

• Gingival Index

  Baseline

• Gingival Index

  1 month post-operative

Study Arms (2)

Er,Cr:YSGG laser 2780 nm

EXPERIMENTAL

Group A was treated by an Er,Cr:YSGG laser 2780 nm cylindrical tip (tip 600 μm, 45 millijoule /pulse, average power 2.25 W, frequency 50 Hz, pulse duration 60 µs, energy density 43 J/cm2, water 50%, and air 40%). The procedure was performed completely without anesthesia with the laser tip at angulation \~30° and distance of \~1 mm from the gingival tissue. The laser tip was advancing in scanning movement from in the cervical-apical direction in all pigmented areas. The following settings was used to achieve hemostasis in case of the bleeding was present (tip 600 μm, 30 millijoule /pulse, average power 1.5 W, frequency 50 Hz, pulse duration 700 µs, energy density 28.7 J/cm2, water 10%, and air 20%).

Device: Er,Cr:YSGG laser 2780 nm

Diode laser 940 nm

EXPERIMENTAL

Group B was treated with diode 940 nm Laser. The procedure was performed with a pencil-sized handpiece containing a 400 µm lasing fiber (400 μm initiated tip, average power 0.8 watts, Pulsed mode, Duty cycle 20%, Pulse duration 10 μs, energy density 636.9 J/cm2 per second, no water or air). Infiltration anesthesia was injected for B group . The laser tip was placed in angle \~30° with the gingival surface. Short light paint brush strokes were used in the cervical-apical direction in all pigmented areas.

Device: Diode laser 940 nm

Interventions

Er,Cr:YSGG laser 2780 nm DEVICE

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

Er,Cr:YSGG laser 2780 nm

Diode laser 940 nm DEVICE

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

Diode laser 940 nm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academy of Laser Dentistry - Gulf Laser Chapter: lead
• Damascus University: collaborator

Study Sites (1)

Dr. Tamim Dental Polyclinic

Doha, 13876, Qatar

Location

Related Publications (3)

• 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.

  PMID: 22676819 RESULT

• 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.

  PMID: 31951510 RESULT

• 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.

  PMID: 23003920 RESULT

MeSH Terms

Conditions

Hyperpigmentation; Vitiligo

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Hypopigmentation

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Omar Hamadah, PhD

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation of the patients into the two treatment groups was carried out using randomization table with allocation ratio 1:1. Participants, investigator, the tree external clinical examiners were blinded about the allocation of the patient in the treatment group. Care provider didn't interfere in collecting and analysing the data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 23, 2020
• Study Start: April 5, 2015
• Primary Completion: September 30, 2018
• Study Completion: October 20, 2019
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)