Gingival HyperpigmentationAPGHNCT07672587
Comparison of Er-YAG Laser, Air Polishing, and Surgical Excision for Gingival Hyperpigmentation
A study testing Er:YAG Laser Therapy, Air Polishing with Erythritol Powder and Air Polishing with Sodium Bicarbonate Powder in people with Gingival Hyperpigmentation and Oral Pigmentation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aimed to compare the effectiveness of different treatment approaches for physiologic gingival hyperpigmentation. Participants with gingival melanin pigmentation were randomly assigned to one of four treatment groups: Er:YAG laser treatment, air polishing with erythritol… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Hyperpigmentation, Oral Pigmentation
- What is being tested?
- Er:YAG Laser Therapy, Air Polishing with Erythritol Powder and Air Polishing with Sodium Bicarbonate Powder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged between 18 and 50 years
- Systemically healthy individuals
- Presence of physiologic gingival hyperpigmentation in the anterior maxillary or mandibular gingiva
- Individuals seeking esthetic treatment for gingival pigmentation
- Presence of adequate oral hygiene and periodontal health before treatment
- Willingness to participate in the study and provide written informed consent
- Agreement to attend all follow-up visits during the study period
Who cannot join
- Presence of systemic diseases or conditions that may affect wound healing
- Smoking or use of tobacco products
- Pregnancy or lactation
- History of periodontal therapy or gingival depigmentation treatment in the study area
- Presence of active periodontal disease or gingival inflammation at baseline
- Use of medications affecting gingival tissues or wound healing
- Individuals with non-physiologic oral pigmentation associated with systemic disorders, medication use, or syndromic conditions
- Inability or unwillingness to comply with study protocol and follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Dentistry
Samsun, Atakum, 55200
About this study
Official title: Comparison of Laser, Guided Biofilm Therapy, and Conventional Surgical Approaches in the Treatment of Gingival Hyperpigmentation: Evaluation of Clinical Outcomes and Patient Satisfaction
This randomized controlled clinical trial aimed to compare the effectiveness of different treatment approaches for physiologic gingival hyperpigmentation. Participants with gingival melanin pigmentation were randomly assigned to one of four treatment groups: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, or conventional surgical excision. Clinical outcomes were evaluated using pigmentation index scores, digital image analysis, and color measurements at baseline and follow-up visits. Patient-centered outcomes, including postoperative discomfort and satisfaction, were also assessed. The study sought to determine whether air polishing techniques could provide clinical outcomes comparable to conventional treatment approaches while improving patient comfort and satisfaction.
Read the detailed description
Physiologic gingival hyperpigmentation is a common esthetic condition caused by excessive melanin deposition within the gingival epithelium. Several treatment approaches have been proposed to eliminate gingival pigmentation, including conventional surgical techniques, laser applications, and minimally invasive air polishing systems. Although conventional surgical excision and laser therapy are widely used, alternative approaches that may reduce postoperative discomfort while maintaining comparable clinical outcomes remain of clinical interest.
The purpose of this randomized controlled clinical trial was to compare the clinical effectiveness and patient-related outcomes of four different treatment modalities for gingival hyperpigmentation: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, and conventional surgical excision.
Eligible participants diagnosed with physiologic gingival melanin hyperpigmentation were randomly allocated into four parallel treatment groups. Clinical pigmentation changes were assessed using standardized clinical photographs, pigmentation index scoring systems, digital color analysis, and quantitative color measurements during baseline and follow-up examinations over a three-month period. Secondary evaluations included postoperative discomfort assessment and patient satisfaction measurements.
The study was designed to evaluate whether minimally invasive air polishing approaches could achieve clinical outcomes comparable to established treatment methods while providing improved patient comfort during the healing period.
- Conditions
- Gingival Hyperpigmentation, Oral Pigmentation
- Being tested
- Er:YAG Laser Therapy, Air Polishing with Erythritol Powder, Air Polishing with Sodium Bicarbonate Powder, Conventional Surgical Excision
- Keywords
- Physiologic Gingival Hyperpigmentation, Air Polishing, Er:YAG Laser, Gingival Depigmentation, Melanin Pigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG Laser TherapyProcedure or surgery
Gingival depigmentation was performed using Er:YAG laser therapy to remove physiologic gingival melanin pigmentation. The procedure was applied according to the manufacturer's recommended clinical protocol for soft tissue ablation.
Air Polishing with Erythritol PowderProcedure or surgery
Gingival depigmentation was performed using an air polishing system with erythritol powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol.
Air Polishing with Sodium Bicarbonate PowderProcedure or surgery
Gingival depigmentation was performed using an air polishing system with sodium bicarbonate powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol.
Conventional Surgical ExcisionProcedure or surgery
Gingival depigmentation was performed using a conventional surgical excision technique for the removal of physiologic gingival melanin pigmentation. The procedure involved surgical removal of the pigmented gingival epithelium using conventional periodontal surgical instruments according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG Laser Group | Experimental | Participants assigned to this group received gingival depigmentation treatment using Er:YAG laser for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. Receives: Procedure: Er:YAG Laser Therapy |
| Air Polishing Erythritol Group | Experimental | Participants assigned to this group received gingival depigmentation treatment using an air polishing device with erythritol powder for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. Receives: Procedure: Air Polishing with Erythritol Powder |
| Air Polishing Sodium Bicarbonate Group | Experimental | Participants assigned to this group received gingival depigmentation treatment using an air polishing device with sodium bicarbonate powder for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. Receives: Procedure: Air Polishing with Sodium Bicarbonate Powder |
| Conventional Surgical Excision Group | Active comparator | Participants assigned to this group received conventional surgical gingival depigmentation treatment by surgical excision for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. Receives: Procedure: Conventional Surgical Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RGB Color Values
Changes in gingival color will be quantitatively assessed using standardized digital photographs and RGB color analysis following depigmentation procedures.
Measured: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
Color Difference (Delta E)
Gingival color change following treatment will be evaluated by calculating color difference values using the Delta E (CIE76) formula based on digital photographic analysis.
Measured: 7 days after treatment, 1 month after treatment, and 3 months after treatment
Change in Pigmented Area
The extent of gingival pigmentation will be quantitatively assessed by measuring the pigmented gingival area from standardized digital photographs.
Measured: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
Change in Dummett Oral Pigmentation Index (DOPI)
Gingival pigmentation intensity will be clinically evaluated using the Dummett Oral Pigmentation Index (DOPI) to assess treatment effectiveness.
Measured: Baseline, 1 months after treatment, 3 months after treatment
Secondary outcomes (3)
Postoperative Pain Level
Postoperative pain associated with each treatment procedure will be assessed using the Visual Analog Scale (VAS).
Measured: Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
Patient Esthetic Satisfaction
Patient satisfaction regarding esthetic treatment outcomes will be evaluated using a Visual Analog Scale (VAS).
Measured: Baseline, 3 months after treatment
Clinician Esthetic Evaluation
Esthetic treatment outcomes will be independently evaluated by blinded clinicians to assess overall esthetic improvement after treatment.
Measured: Baseline, 1 months after treatment, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HyperpigmentationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Arslan, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672587
- Sponsor's protocol ID
- OMU-KAEK-2025/1248
- Acronym
- APGH
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data generated during this study will not be publicly shared because no formal data-sharing plan has been established and the study was conducted as part of an institutional academic research project.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laser, Guided Biofilm Therapy, and Conventional Surgical Approaches in the Treatment of Gingival Hyperpigmentation: Evaluation of Clinical Outcomes and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07672587
- Acronym / sponsor ID
- APGH / OMU-KAEK-2025/1248
- Conditions
- Gingival Hyperpigmentation, Oral Pigmentation
- Keywords
- Physiologic Gingival Hyperpigmentation, Air Polishing, Er:YAG Laser, Gingival Depigmentation, Melanin Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 29 Jun 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.
This randomized controlled clinical trial aimed to compare the effectiveness of different treatment approaches for physiologic gingival hyperpigmentation. Participants with gingival melanin pigmentation were randomly assigned to one of four treatment groups: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, or conventional surgical excision. Clinical outcomes were evaluated using pigmentation index scores, digital image analysis, and color measurements at baseline and follow-up visits. Patient-centered outcomes, including postoperative discomfort and satisfaction, were also assessed. The study sought to determine whether air polishing techniques could provide clinical outcomes comparable to conventional treatment approaches while improving patient comfort and satisfaction.
Detailed description
Physiologic gingival hyperpigmentation is a common esthetic condition caused by excessive melanin deposition within the gingival epithelium. Several treatment approaches have been proposed to eliminate gingival pigmentation, including conventional surgical techniques, laser applications, and minimally invasive air polishing systems. Although conventional surgical excision and laser therapy are widely used, alternative approaches that may reduce postoperative discomfort while maintaining comparable clinical outcomes remain of clinical interest.
The purpose of this randomized controlled clinical trial was to compare the clinical effectiveness and patient-related outcomes of four different treatment modalities for gingival hyperpigmentation: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, and conventional surgical excision.
Eligible participants diagnosed with physiologic gingival melanin hyperpigmentation were randomly allocated into four parallel treatment groups. Clinical pigmentation changes were assessed using standardized clinical photographs, pigmentation index scoring systems, digital color analysis, and quantitative color measurements during baseline and follow-up examinations over a three-month period. Secondary evaluations included postoperative discomfort assessment and patient satisfaction measurements.
The study was designed to evaluate whether minimally invasive air polishing approaches could achieve clinical outcomes comparable to established treatment methods while providing improved patient comfort during the healing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser Group | Experimental | Procedure: Er:YAG Laser TherapyParticipants assigned to this group received gingival depigmentation treatment using Er:YAG laser for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. |
| Air Polishing Erythritol Group | Experimental | Procedure: Air Polishing with Erythritol PowderParticipants assigned to this group received gingival depigmentation treatment using an air polishing device with erythritol powder for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. |
| Air Polishing Sodium Bicarbonate Group | Experimental | Procedure: Air Polishing with Sodium Bicarbonate PowderParticipants assigned to this group received gingival depigmentation treatment using an air polishing device with sodium bicarbonate powder for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. |
| Conventional Surgical Excision Group | Active comparator | Procedure: Conventional Surgical ExcisionParticipants assigned to this group received conventional surgical gingival depigmentation treatment by surgical excision for the removal of physiologic gingival melanin pigmentation. Clinical and patient-reported outcomes were evaluated during the follow-up period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals aged between 18 and 50 years
- Systemically healthy individuals
- Presence of physiologic gingival hyperpigmentation in the anterior maxillary or mandibular gingiva
- Individuals seeking esthetic treatment for gingival pigmentation
- Presence of adequate oral hygiene and periodontal health before treatment
Key exclusion criteria (8 listed)
- Presence of systemic diseases or conditions that may affect wound healing
- Smoking or use of tobacco products
- Pregnancy or lactation
- History of periodontal therapy or gingival depigmentation treatment in the study area
- Presence of active periodontal disease or gingival inflammation at baseline
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 |
|---|---|---|
| Er:YAG Laser TherapyGingival depigmentation was performed using Er:YAG laser therapy to remove physiologic gingival melanin pigmentation. The procedure was applied according to the manufacturer's recommended clinical protocol for soft tissue ablation. | Procedure or surgery | Er:YAG Laser Group |
| Air Polishing with Erythritol PowderGingival depigmentation was performed using an air polishing system with erythritol powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol. | Procedure or surgery | Air Polishing Erythritol Group |
| Air Polishing with Sodium Bicarbonate PowderGingival depigmentation was performed using an air polishing system with sodium bicarbonate powder to remove physiologic gingival melanin pigmentation. The procedure was carried out by applying pressurized air and powder particles to the pigmented gingival surface according to the treatment protocol. | Procedure or surgery | Air Polishing Sodium Bicarbonate Group |
| Conventional Surgical ExcisionGingival depigmentation was performed using a conventional surgical excision technique for the removal of physiologic gingival melanin pigmentation. The procedure involved surgical removal of the pigmented gingival epithelium using conventional periodontal surgical instruments according to standard clinical practice. | Procedure or surgery | Conventional Surgical Excision Group |
Primary outcome
Change in RGB Color Values
Time frame: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
Changes in gingival color will be quantitatively assessed using standardized digital photographs and RGB color analysis following depigmentation procedures.
Color Difference (Delta E)
Time frame: 7 days after treatment, 1 month after treatment, and 3 months after treatment
Gingival color change following treatment will be evaluated by calculating color difference values using the Delta E (CIE76) formula based on digital photographic analysis.
Change in Pigmented Area
Time frame: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
The extent of gingival pigmentation will be quantitatively assessed by measuring the pigmented gingival area from standardized digital photographs.
Change in Dummett Oral Pigmentation Index (DOPI)
Time frame: Baseline, 1 months after treatment, 3 months after treatment
Gingival pigmentation intensity will be clinically evaluated using the Dummett Oral Pigmentation Index (DOPI) to assess treatment effectiveness.
3 secondary outcomes
Postoperative Pain Level
Time frame: Day 1 after treatment, Day 3 after treatment, and Day 7 after treatment
Patient Esthetic Satisfaction
Time frame: Baseline, 3 months after treatment
Clinician Esthetic Evaluation
Time frame: Baseline, 1 months after treatment, 3 months after 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 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data generated during this study will not be publicly shared because no formal data-sharing plan has been established and the study was conducted as part of an institutional academic research project.
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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 Er:YAG Laser Therapy, Air Polishing with Erythritol Powder and Air Polishing with Sodium Bicarbonate Powder in people with Gingival Hyperpigmentation and Oral Pigmentation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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 29 Jun 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 Turkey (Türkiye). 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?
Change in RGB Color Values (time frame: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment). The study lists 4 primary outcomes in all. 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 29 Jun 2026.