Physiological Gingival PigmentationMB-Laser-GPNCT06834087
Laser Treatment With Methylene Blue vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: A Randomized Clinical Trial
A study testing Laser-Assisted Gingival Depigmentation, Drug: Conventional Methylene Blue-Mediated Photodynamic Therapy and Drug: Methylene Blue Nanoparticle-Mediated Photodynamic Therapy in people with Physiological Gingival Pigmentation, run by Roaa Hadi Hussein Jasem at 1 site in Egypt.
Trial summary
This prospective, randomized, controlled, single-blinded, three-arm clinical trial compared the clinical effectiveness of conventional methylene blue-mediated photodynamic therapy (MB-PDT) and methylene blue nanoparticle-mediated photodynamic therapy (MB-NP-PDT) as adjuncts to diode-laser treatment of physiological… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Physiological Gingival Pigmentation
- What is being tested?
- Laser-Assisted Gingival Depigmentation, Drug: Conventional Methylene Blue-Mediated Photodynamic Therapy and Drug: Methylene Blue Nanoparticle-Mediated Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 15 Nov 2025
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with physiological gingival pigmentation confirmed by clinical examination.
- Age range: 18-50 years.
- Patients with no history of systemic diseases or conditions that could affect wound healing (e.g., diabetes, autoimmune diseases).
- Patients willing to undergo laser treatment and provide informed consent.
- Non-smokers or individuals who have stopped smoking for at least six months.
Who cannot join
- Patients with pathological gingival pigmentation (e.g., associated with syndromes or systemic conditions).
- Use of medications affecting pigmentation or healing (e.g., anticoagulants, immunosuppressants).
- Pregnant or lactating women or those taking contraceptive drugs.
- Individuals with known allergies to methylene blue or nanoparticles.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University, Faculty of Oral and Dental Medicine
Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, 33511
About this study
Official title: Comparative Evaluation Of Methylene Blue And Methylene Blue Nanoparticles Assisted Photodynamic Therapy As Adjunctive To Laser Treatment Of Physiological Gingival Pigmentation: A Randomized Controlled Clinical Trial
This prospective, randomized, controlled, single-blinded, three-arm clinical trial compared the clinical effectiveness of conventional methylene blue-mediated photodynamic therapy (MB-PDT) and methylene blue nanoparticle-mediated photodynamic therapy (MB-NP-PDT) as adjuncts to diode-laser treatment of physiological gingival pigmentation.
A total of 45 systemically healthy participants with physiological gingival pigmentation were randomly allocated in a 1:1:1 ratio to three groups: diode-laser gingival depigmentation alone, conventional 0.1% methylene blue PDT followed by diode-laser depigmentation, or 0.1% methylene blue nanoparticle PDT followed by diode-laser depigmentation.
Participants were followed for 6 months. The study assessed gingival pigmentation reduction, complete pigmentation clearance, recurrence, objective gingival color changes, epithelialization and healing time, postoperative pain, patient satisfaction, and treatment-related adverse events.
- Conditions
- Physiological Gingival Pigmentation
- Being tested
- Laser-Assisted Gingival Depigmentation, Drug: Conventional Methylene Blue-Mediated Photodynamic Therapy, Drug: Methylene Blue Nanoparticle-Mediated Photodynamic Therapy
- Keywords
- Gingival Pigmentation, Laser Therapy, Photodynamic Therapy, Methylene Blue, Nanoparticles, Periodontology, Aesthetic Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-Assisted Gingival DepigmentationProcedure or surgery
This intervention involved diode-laser gingival depigmentation using the SiroLaser Blue system (Dentsply Sirona) at a wavelength of 970 nm and an output power of 1.5 W in continuous-wave mode. A 320-µm fiber tip was used in contact mode and moved continuously with gentle sweeping strokes over the pigmented gingival surface for approximately 30 seconds per treatment site.
Drug: Conventional Methylene Blue-Mediated Photodynamic TherapyDrug
This intervention consisted of applying a 0.1% conventional methylene blue solution uniformly to the pigmented gingival surface using a sterile microbrush. The photosensitizer was allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual photosensitizer. Diode-laser gingival depigmentation was then performed using the 970-nm, 1.5-W continuous-wave protocol with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site.
Drug: Methylene Blue Nanoparticle-Mediated Photodynamic TherapyDrug
This intervention consisted of applying a 0.1% methylene blue nanoparticle formulation uniformly to the pigmented gingival surface using a sterile microbrush. The formulation was allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual formulation. Diode-laser gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Control): Diode-Laser Gingival Depigmentation Alone | Active comparator | Participants assigned to this arm received diode-laser gingival depigmentation alone using the SiroLaser Blue diode laser (Dentsply Sirona). The laser was operated at a wavelength of 970 nm and an output power of 1.5 W in continuous-wave mode. A 320-µm fiber tip was used in contact mode and moved continuously with gentle sweeping strokes over the pigmented gingival surface for approximately 30 seconds per treatment site. Receives: Procedure: Laser-Assisted Gingival Depigmentation |
| Arm 2: Conventional Methylene Blue-PDT Plus Diode-Laser Depigmentation | Experimental | Participants assigned to this arm received photodynamic therapy using conventional 0.1% methylene blue before diode-laser gingival depigmentation. The methylene blue solution was applied uniformly to the pigmented gingival surface using a sterile microbrush and allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual photosensitizer. Gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site. Receives: Drug: Drug: Conventional Methylene Blue-Mediated Photodynamic Therapy |
| Arm 3: Methylene Blue Nanoparticle-PDT Plus Diode-Laser Depigmentation | Experimental | Participants assigned to this arm received photodynamic therapy using a 0.1% methylene blue nanoparticle formulation before diode-laser gingival depigmentation. The nanoparticle formulation was applied uniformly to the pigmented gingival surface using a sterile microbrush and allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual formulation. Gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site. Receives: Drug: Drug: Methylene Blue Nanoparticle-Mediated Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Gingival Pigmentation
The primary outcome will be assessed by evaluating changes in gingival pigmentation using clinical photographs and a standardized pigmentation index. Digital images of the treated gingival areas will be analyzed for pigmentation intensity reduction using imaging software. The pigmentation index scores range from:
Score 0: Absence of pigmentation
Score 1: Spots of brown to black color
Score 2: Brown to black patches without diffuse pigmentation
Score 3: Diffuse brown to black pigmentation
Measured: Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment
Secondary outcomes (4)
Healing Time
The duration required for complete epithelialization of the treated gingival area will be recorded. Visual inspection at follow-up visits will determine the time until there is no visible inflammation, erythema, or delayed healing.
Measured: 1 Month Post-Treatment
Patient Satisfaction
Patient satisfaction will be assessed using a Visual Analog Scale (VAS) questionnaire. Patients will rate their satisfaction with the treatment, including aesthetic improvement, comfort during the procedure, and overall experience on a scale from 0 (completely dissatisfied) to 10 (completely satisfied).
Measured: 1 Month, 3 Months, and 6 Months Post-Treatment
Recurrence of Gingival Pigmentation
The degree of gingival pigmentation recurrence will be evaluated using clinical and photographic records. Re-pigmentation percentage will be calculated and documented at each follow-up visit.
Measured: 3 Months and 6 Months Post-Treatment
Adverse Events
Any adverse effects such as persistent erythema, ulceration, or patient-reported pain post-treatment will be documented. A scoring system will be used to assess the severity of these events (e.g., mild, moderate, severe).
Measured: Throughout the study duration (up to 6 Months Post-Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start15 Mar 2025
- Primary completion14 Sep 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Gingival PigmentationStudies 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
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roaa Hadi Hussein Jasem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roaa Hadi Hussein Jasem, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834087
- Sponsor's protocol ID
- KFSIRB200-489
- Acronym
- MB-Laser-GP
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of Methylene Blue And Methylene Blue Nanoparticles Assisted Photodynamic Therapy As Adjunctive To Laser Treatment Of Physiological Gingival Pigmentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06834087
- Acronym / sponsor ID
- MB-Laser-GP / KFSIRB200-489
- Conditions
- Physiological Gingival Pigmentation
- Keywords
- Gingival Pigmentation, Laser Therapy, Photodynamic Therapy, Methylene Blue, Nanoparticles, Periodontology, Aesthetic Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Roaa Hadi Hussein JasemUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 19 Feb 2025 (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.
This prospective, randomized, controlled, single-blinded, three-arm clinical trial compared the clinical effectiveness of conventional methylene blue-mediated photodynamic therapy (MB-PDT) and methylene blue nanoparticle-mediated photodynamic therapy (MB-NP-PDT) as adjuncts to diode-laser treatment of physiological gingival pigmentation.
A total of 45 systemically healthy participants with physiological gingival pigmentation were randomly allocated in a 1:1:1 ratio to three groups: diode-laser gingival depigmentation alone, conventional 0.1% methylene blue PDT followed by diode-laser depigmentation, or 0.1% methylene blue nanoparticle PDT followed by diode-laser depigmentation.
Participants were followed for 6 months. The study assessed gingival pigmentation reduction, complete pigmentation clearance, recurrence, objective gingival color changes, epithelialization and healing time, postoperative pain, patient satisfaction, and treatment-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Control): Diode-Laser Gingival Depigmentation Alone | Active comparator | Procedure: Laser-Assisted Gingival DepigmentationParticipants assigned to this arm received diode-laser gingival depigmentation alone using the SiroLaser Blue diode laser (Dentsply Sirona). The laser was operated at a wavelength of 970 nm and an output power of 1.5 W in continuous-wave mode. A 320-µm fiber tip was used in contact mode and moved continuously with gentle sweeping strokes over the pigmented gingival surface for approximately 30 seconds per treatment site. |
| Arm 2: Conventional Methylene Blue-PDT Plus Diode-Laser Depigmentation | Experimental | Drug: Drug: Conventional Methylene Blue-Mediated Photodynamic TherapyParticipants assigned to this arm received photodynamic therapy using conventional 0.1% methylene blue before diode-laser gingival depigmentation. The methylene blue solution was applied uniformly to the pigmented gingival surface using a sterile microbrush and allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual photosensitizer. Gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site. |
| Arm 3: Methylene Blue Nanoparticle-PDT Plus Diode-Laser Depigmentation | Experimental | Drug: Drug: Methylene Blue Nanoparticle-Mediated Photodynamic TherapyParticipants assigned to this arm received photodynamic therapy using a 0.1% methylene blue nanoparticle formulation before diode-laser gingival depigmentation. The nanoparticle formulation was applied uniformly to the pigmented gingival surface using a sterile microbrush and allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual formulation. Gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with physiological gingival pigmentation confirmed by clinical examination.
- Age range: 18-50 years.
- Patients with no history of systemic diseases or conditions that could affect wound healing (e.g., diabetes, autoimmune diseases).
- Patients willing to undergo laser treatment and provide informed consent.
- Non-smokers or individuals who have stopped smoking for at least six months.
Key exclusion criteria (4 listed)
- Patients with pathological gingival pigmentation (e.g., associated with syndromes or systemic conditions).
- Use of medications affecting pigmentation or healing (e.g., anticoagulants, immunosuppressants).
- Pregnant or lactating women or those taking contraceptive drugs.
- Individuals with known allergies to methylene blue or nanoparticles.
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 |
|---|---|---|
| Laser-Assisted Gingival DepigmentationThis intervention involved diode-laser gingival depigmentation using the SiroLaser Blue system (Dentsply Sirona) at a wavelength of 970 nm and an output power of 1.5 W in continuous-wave mode. A 320-µm fiber tip was used in contact mode and moved continuously with gentle sweeping strokes over the pigmented gingival surface for approximately 30 seconds per treatment site. | Procedure or surgery | Arm 1 (Control): Diode-Laser Gingival Depigmentation Alone |
| Drug: Conventional Methylene Blue-Mediated Photodynamic TherapyThis intervention consisted of applying a 0.1% conventional methylene blue solution uniformly to the pigmented gingival surface using a sterile microbrush. The photosensitizer was allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual photosensitizer. Diode-laser gingival depigmentation was then performed using the 970-nm, 1.5-W continuous-wave protocol with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site. | Drug | Arm 2: Conventional Methylene Blue-PDT Plus Diode-Laser Depigmentation |
| Drug: Methylene Blue Nanoparticle-Mediated Photodynamic TherapyThis intervention consisted of applying a 0.1% methylene blue nanoparticle formulation uniformly to the pigmented gingival surface using a sterile microbrush. The formulation was allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual formulation. Diode-laser gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site. | Drug | Arm 3: Methylene Blue Nanoparticle-PDT Plus Diode-Laser Depigmentation |
Primary outcome
Reduction in Gingival Pigmentation
Time frame: Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment
The primary outcome will be assessed by evaluating changes in gingival pigmentation using clinical photographs and a standardized pigmentation index. Digital images of the treated gingival areas will be analyzed for pigmentation intensity reduction using imaging software. The pigmentation index scores range from: Score 0: Absence of pigmentation Score 1: Spots of brown to black color Score 2: Brown to black patches without diffuse pigmentation Score 3: Diffuse brown to black pigmentation
4 secondary outcomes
Healing Time
Time frame: 1 Month Post-Treatment
Patient Satisfaction
Time frame: 1 Month, 3 Months, and 6 Months Post-Treatment
Recurrence of Gingival Pigmentation
Time frame: 3 Months and 6 Months Post-Treatment
Adverse Events
Time frame: Throughout the study duration (up to 6 Months Post-Treatment)
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 10 Sep 2026.
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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 Laser-Assisted Gingival Depigmentation, Drug: Conventional Methylene Blue-Mediated Photodynamic Therapy and Drug: Methylene Blue Nanoparticle-Mediated Photodynamic Therapy in people with Physiological Gingival Pigmentation, run by Roaa Hadi Hussein Jasem at 1 site in Egypt.
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 5 inclusion and 4 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 10 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 Egypt. 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?
Reduction in Gingival Pigmentation (time frame: Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.