Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode: A Randomized Controlled Clinical Trial
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All trials for Physiological Gingival Hyperpigmentation All trials of Gingival depigmentation using blue laser in non-contact mode All trials of Gingival depigmentation using blue laser in contact mode
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Non-contact group | Experimental | Procedure: Gingival depigmentation using blue laser in non-contact mode | This group underwent gingival depigmentation using blue laser in non-contact mode. |
| Contact group | Active comparator | Procedure: Gingival depigmentation using blue laser in contact mode | This group underwent gingival depigmentation using blue laser in contact mode. |
- 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.
- 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.
+Outcome measures
Primary outcomes
- Postoperative pain [immediately after the procedure, 24 hours post operatively, and 7 days post operatively.]: 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
- Degree of gingival pigmentation [1 and 3 months after completion of the procedure.]: Degree of gingival pigmentation was assessed using the Dummett Oral Pigmentation Index (DOPI).
- Extent and distribution of gingival pigmentation [1 and 3 months after completion of the procedure.]: Extent and distribution of gingival pigmentation were measured using Hedin Melanin Index (HMI)
Secondary outcomes
- Changes in gingival color [1 and 3 months after completion of the procedure]: 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
+Eligibility
Sex: All, ages: 18 Years to 40 Years
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:
* 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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Beirut Arab University | Beirut | Lebanon | |
+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. PMID 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. PMID 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. PMID 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. PMID 24034073