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CompletedNCT07836894Updated Sep 23, 2026

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

An interventional study of Gingival depigmentation using blue laser in non-contact mode and Gingival depigmentation using blue laser in contact mode in Physiological Gingival Hyperpigmentation, sponsored by Beirut Arab University. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Beirut Arab University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2025, registered Sep 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Physiological Gingival Hyperpigmentation

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Keywords

  • physiological gingival hyperpigmentation
  • blue diode laser
  • gingival pigmentation
  • contact laser
  • non-contact laser
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's enrollment of 20 is below the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Beirut Arab University is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with poor oral hygiene
  • patients
  • Patients with uncontrolled systemic diseases
  • Patients having at the treatment site
  • Patients with photosensitive conditions or on photosensitizing medications
  • Pregnant women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Non-contact group

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

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

  • Active comparator
    Contact group

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

    Procedure: Gingival depigmentation using blue laser in contact mode

Interventions

  • ProcedureGingival depigmentation using blue laser in non-contact mode

    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.

  • ProcedureGingival depigmentation using blue laser in contact mode

    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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. Degree of gingival pigmentation

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

    Time frame: 1 and 3 months after completion of the procedure.

  3. Extent and distribution of gingival pigmentation

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

    Time frame: 1 and 3 months after completion of the procedure.

Secondary outcomes

  1. Changes in gingival color

    Changes in gingival color will be assessed by calculating ΔE from standardized digital photographs using CIELAB L\*, a\*, and b\* color coordinates. ΔE represents the overall color difference between baseline and postoperative measurements. Unit of measure: None/ dimensionless

    Time frame: 1 and 3 months after completion of the procedure

07

Study locations

1 site
  • Beirut Arab University
    Beirut, Lebanon
08

References and documents

Publications

  • 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
  • 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.
  • 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
  • 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. PubMed 39055786 ↗
  • 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. PubMed 36579240 ↗
  • 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. PubMed 39455079 ↗
  • 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. PubMed 24034073 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07836894
Lead sponsor
Beirut Arab University
Responsible party
Sara Hammoud (BDS, Beirut Arab University) — Principal investigator
First posted
Sep 23, 2026
Start date
Sep 1, 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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