Physiological Gingival HyperpigmentationNCT07836894
Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode
A study testing Gingival depigmentation using blue laser in non-contact mode and Gingival depigmentation using blue laser in contact mode in people with Physiological Gingival Hyperpigmentation, run by Beirut Arab University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Physiological Gingival Hyperpigmentation
- What is being tested?
- Gingival depigmentation using blue laser in non-contact mode and Gingival depigmentation using blue laser in contact mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with physiological gingival hyperpigmentation.
- Patients free from systemic diseases or with controlled systemic diseases
- Age range between 18 and 40
- Non smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode: A Randomized Controlled Clinical Trial
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
- Being tested
- Gingival depigmentation using blue laser in non-contact mode, Gingival depigmentation using blue laser in contact mode
- Keywords
- physiological gingival hyperpigmentation, blue diode laser, gingival pigmentation, contact laser, non-contact laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival depigmentation using blue laser in non-contact modeProcedure or surgery
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 modeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-contact group | Experimental | This group underwent gingival depigmentation using blue laser in non-contact mode. Receives: 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. Receives: Procedure: Gingival depigmentation using blue laser in contact mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 1 and 3 months after completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Physiological Gingival HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hammoud, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836894
- Sponsor's protocol ID
- 2025-H-0190-D-M-0943
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 39055786Hiramatsu 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 36579240Haque 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 39455079Alawi 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Blue Laser in the Management of Gingival Hyperpigmentation Using Contact vs. Non-contact Mode: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07836894
- Acronym / sponsor ID
- 2025-H-0190-D-M-0943
- Conditions
- Physiological Gingival Hyperpigmentation
- Keywords
- physiological gingival hyperpigmentation, blue diode laser, gingival pigmentation, contact laser, non-contact laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-contact group | Experimental | Procedure: Gingival depigmentation using blue laser in non-contact modeThis group underwent gingival depigmentation using blue laser in non-contact mode. |
| Contact group | Active comparator | Procedure: Gingival depigmentation using blue laser in contact modeThis group underwent gingival depigmentation using blue laser in contact mode. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with physiological gingival hyperpigmentation.
- Patients free from systemic diseases or with controlled systemic diseases
- Age range between 18 and 40
- Non smokers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival depigmentation using blue laser in non-contact modeInfiltration 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. | Procedure or surgery | Non-contact group |
| Gingival depigmentation using blue laser in contact modeInfiltration 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. | Procedure or surgery | Contact group |
Primary outcome
Postoperative pain
Time frame: 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
Time frame: 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
Time frame: 1 and 3 months after completion of the procedure.
Extent and distribution of gingival pigmentation were measured using Hedin Melanin Index (HMI)
1 secondary outcome
Changes in gingival color
Time frame: 1 and 3 months after completion of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- BackgroundRaghu 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
- BackgroundSubhadarsanee, 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.
- BackgroundShah, 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: PubMed 39055786Nik 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.
- Background: PubMed 36579240Hiramatsu 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.
- Background: PubMed 39455079Haque 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.
- Background: PubMed 24034073Alawi 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival depigmentation using blue laser in non-contact mode and Gingival depigmentation using blue laser in contact mode in people with Physiological Gingival Hyperpigmentation, run by Beirut Arab University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: immediately after the procedure, 24 hours post operatively, and 7 days post operatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07836894, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.