Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode

NCT07836894 | Completed

• 1 other identifier: 2025-H-0190-D-M-0943
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare clinical and digital color parameter results of gingival depigmentation using blue laser in both contact and non- contact modes in patients with physiological gingival hyperpigmentation. The main questions it aims to answer are:

• Which intervention will provide less pain?
• Which intervention will provide better gingival depigmentation? Participants will undergo:
• Mechanical plaque removal
• Infiltration using Articaine 4%
• Blue diode laser (445 nm) application to the gingiva either from a 2-mm distance in one group or directly to the gingiva in the other group.

Conditions

Physiological Gingival Hyperpigmentation

Keywords

physiological gingival hyperpigmentation; blue diode laser; gingival pigmentation; contact laser; non-contact laser

Outcome Measures

Primary Outcomes (3)

• Postoperative pain

  Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), with 0 representing no pain and 10 representing the worst pain imaginable. Participants will record their perceived pain following the laser depigmentation procedure. Unit of measure: Score

  immediately after the procedure, 24 hours post operatively, and 7 days post operatively.

• Degree of gingival pigmentation

  Degree of gingival pigmentation was assessed using the Dummett Oral Pigmentation Index (DOPI).

  1 and 3 months after completion of the procedure.

• Extent and distribution of gingival pigmentation

  Extent and distribution of gingival pigmentation were measured using Hedin Melanin Index (HMI)

  1 and 3 months after completion of the procedure.

Secondary Outcomes (1)

• Changes in gingival color

  1 and 3 months after completion of the procedure

Study Arms (2)

Non-contact group

EXPERIMENTAL

This group underwent gingival depigmentation using blue laser in non-contact mode.

Procedure: Gingival depigmentation using blue laser in non-contact mode

Contact group

ACTIVE COMPARATOR

This group underwent gingival depigmentation using blue laser in contact mode.

Procedure: Gingival depigmentation using blue laser in contact mode

Interventions

Gingival depigmentation using blue laser in contact mode PROCEDURE

Infiltration anesthesia using 4% Articaine was given. Blue light laser (445 nm, 1 W) was applied to patients with physiologic hyperpigmentation using 300 µm fiber-optic tip directly touching the target area until ablation was observed.

Contact group

Gingival depigmentation using blue laser in non-contact mode PROCEDURE

Infiltration anesthesia using 4% Articaine was given. Blue light laser (445 nm, 1.5 W) was applied to patients with physiologic hyperpigmentation using 300 µm fiber-optic tip at a distance of 2mm from the target area in constant movement until gingival blanching was observed.

Non-contact group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with physiological gingival hyperpigmentation.
• Patients free from systemic diseases or with controlled systemic diseases
• Age range between 18 and 40
• Non smokers

You may not qualify if:

• Patients with poor oral hygiene
• Immunosuppressed patients
• Patients with uncontrolled systemic diseases
• Patients having malignancies at the treatment site
• Patients with photosensitive conditions or on photosensitizing medications
• Pregnant women

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Related Publications (7)

• Raghu Raaman, A., Pratebha, B., Jananni, M., & Saravanakumar, R. (2015). Computerized intensity values to objectivize Dummett-Gupta classification of physiologic gingival pigmentation. Clinical Advances in Periodontics, 5(2), 140-145. https://doi.org/10.1902/cap.2015.140082

  BACKGROUND

• Subhadarsanee, C., & Dhadse, P. V. (2020). A concise review of gingival depigmentation technique and re-pigmentation. Indian Journal of Forensic Medicine & Toxicology, 14(4), 6769-6775.

  BACKGROUND

• Shah, N., Rai, J., Shah, M., & Gupte, M. (2023). Clinical evaluation and digital photographic analysis: A modern approach to assess gingival depigmentation. World Journal of Dentistry, 14(12), 1085-1091. https://doi.org/10.5005/jp-journals-10015-2344

  BACKGROUND

• Nik Azis NM, Abdul Shukor SN, Razali M, Zakaria HY, Zabarulla NZ. Comparison between clinical and computerized methods for assessing gingival pigmentation. Digit Health. 2024 Jul 21;10:20552076241264154. doi: 10.1177/20552076241264154. eCollection 2024 Jan-Dec.

  PMID: 39055786 BACKGROUND

• Hiramatsu Azevedo L, de Souza AM, Moreira de Freitas P, Tuma R, Cardoso Soares P. Gingival Pigmentation Removal With a High-Power Diode Laser in Non-contact Mode: A Proposed Technique With Two Years of Follow-Up. Cureus. 2022 Nov 26;14(11):e31903. doi: 10.7759/cureus.31903. eCollection 2022 Nov.

  PMID: 36579240 BACKGROUND

• Haque AU, Rastogi PK, Lal N, Singhal R. Blue laser-assisted depigmentation of gingiva using non-ablative technique. BMJ Case Rep. 2024 Oct 24;17(10):e260493. doi: 10.1136/bcr-2024-260493.

  PMID: 39455079 BACKGROUND

• Alawi F. Pigmented lesions of the oral cavity: an update. Dent Clin North Am. 2013 Oct;57(4):699-710. doi: 10.1016/j.cden.2013.07.006. Epub 2013 Aug 15.

  PMID: 24034073 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BDS

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

LE (1)