Physiologic Gingival Melanin PigmentationNCT07841119
Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
A study testing 940 nm GaAlAs Diode Laser and Ceramic Soft Tissue Trimmer in people with Physiologic Gingival Melanin Pigmentation, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This randomized split-mouth clinical trial will compare the effectiveness of a 940 nm GaAlAs diode laser and a ceramic soft tissue trimmer for the treatment of physiologic gingival melanin pigmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physiologic Gingival Melanin Pigmentation
- What is being tested?
- 940 nm GaAlAs Diode Laser and Ceramic Soft Tissue Trimmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Periodontal health, with gingival index (GI) ≤1, bleeding on probing (BOP) ≤10%, probing depths ≤3 mm, and no periodontitis.
- Thick gingival phenotype with moderate to severe physiologic melanin pigmentation, corresponding to DOPI scores of 2-3, affecting the facial gingiva of the anterior and premolar regions bilaterally.
- Good oral hygiene, with plaque index (PI) ≤1 and calculus index (CI) ≤1.
Who cannot join
- Thin gingival phenotype at the treatment sites.
- Uncontrolled systemic diseases, including cardiovascular disease, hypertension, or diabetes mellitus.
- Pregnancy or lactation.
- Use of medications or presence of conditions affecting hemostasis or wound healing.
- Oral pigmentation attributable to causes other than physiologic melanin pigmentation, including metallic pigmentation, amalgam tattoo, traumatic tattoo, or pigmentation associated with malignant conditions.
- Use of medications or chemical agents known to induce oral pigmentation, including antimalarial drugs, minocycline, ketoconazole, or oral contraceptives.
- Current smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, 749000
Huy Gia Ho, DDS, +84942560496, ghuygl@gmail.com
About this study
Official title: Comparison of Gingival Depigmentation Using a 940 nm GaAlAs Diode Laser and Ceramic Bur: A Split-Mouth Randomized Clinical Trial
This randomized split-mouth clinical trial will compare the effectiveness of a 940 nm GaAlAs diode laser and a ceramic soft tissue trimmer for the treatment of physiologic gingival melanin pigmentation. Each participant will receive both treatment modalities in separate gingival regions according to a randomized allocation. Changes in gingival pigmentation will be evaluated using clinical pigmentation indices and digital image analysis. Participants will be followed at 1, 3, and 6 months after treatment to assess pigmentation reduction and repigmentation.
Read the detailed description
Physiologic gingival melanin pigmentation may affect smile aesthetics and may be treated using several depigmentation techniques. This study is designed as a randomized split-mouth clinical trial comparing a 940 nm GaAlAs diode laser (Epic X, BIOLASE) with a ceramic soft tissue trimmer for gingival depigmentation.
Eligible participants with physiologic gingival melanin pigmentation will receive both interventions in paired gingival regions. Treatment allocation will be randomized. Clinical and photographic assessments will be performed at baseline and during follow-up visits at 1, 3, and 6 months. Gingival pigmentation will be evaluated based on pigmentation intensity and the extent of pigmented gingival area. The study will also assess the persistence or recurrence of pigmentation during follow-up.
- Being tested
- 940 nm GaAlAs Diode Laser, Ceramic Soft Tissue Trimmer
- Keywords
- Gingival depigmentation, Gingival melanin pigmentation, Diode laser, Ceramic soft tissue trimmer, Split-mouth randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
940 nm GaAlAs Diode LaserDevice
Also called EPIC X (BIOLASE)
Gingival depigmentation is performed using a 940 nm GaAlAs diode laser (EPIC X, BIOLASE) according to the study protocol.
Ceramic Soft Tissue TrimmerDevice
Also called NTI Tissue Trimmer
Gingival depigmentation is performed using a ceramic soft tissue trimmer (NTI) according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | Gingival depigmentation is performed in one randomly assigned gingival region using a 940 nm GaAlAs diode laser (EpicX, Biolase). Receives: Device: 940 nm GaAlAs Diode Laser |
| Ceramic Bur Group | Active comparator | Gingival depigmentation is performed in the contralateral gingival region using a ceramic soft tissue trimmer (NTI). Receives: Device: Ceramic Soft Tissue Trimmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dummett Oral Pigmentation Index (DOPI)
Gingival pigmentation intensity is assessed using the Dummett Oral Pigmentation Index (DOPI), scored from 0 to 3: score 0 = no clinical pigmentation, with pink gingiva; score 1 = mild pigmentation, characterized by light-brown gingiva; score 2 = moderate pigmentation, characterized by medium-brown or mixed pink and brown gingiva; and score 3 = heavy pigmentation, characterized by deep-brown or bluish-black gingiva. Higher scores indicate greater gingival pigmentation intensity. DOPI scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer over follow-up.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Pigmented Gingival Area
The pigmented gingival area is quantified from standardized clinical photographs using digital image analysis and expressed as the percentage of the total gingival area showing melanin pigmentation. Changes are compared between the two treatment modalities over follow-up.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Extent of Gingival Pigmentation According to the Ponnaiyan Classification
The extent and distribution of gingival melanin pigmentation are assessed according to the Ponnaiyan classification (2013), which categorizes pigmentation into six types based on the gingival areas involved: Type I, pigmentation limited to the attached gingiva; Type II, pigmentation involving the attached gingiva and interdental papillae; Type III, pigmentation involving the attached gingiva, marginal gingiva, and interdental papillae; Type IV, pigmentation limited to the marginal gingiva; Type V, pigmentation limited to the interdental papillae; and Type VI, pigmentation involving the marginal gingiva and interdental papillae. Changes in Ponnaiyan classification are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer during follow-up.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Secondary outcomes (8)
Surgical Procedure Time
The duration of each gingival depigmentation procedure is recorded in minutes from the beginning to the completion of treatment for the assigned gingival region.
Measured: During the surgical procedure
Perioperative Bleeding
Bleeding is assessed during the gingival depigmentation procedure and at 1 day after treatment using the Varghese bleeding scale. Bleeding is scored as follows: score 0 = no bleeding, with the surgical site clean and dry; score 1 = slight oozing, with blood present but not spreading; and score 2 = evident bleeding, with sufficient blood flow to fill the oral cavity. Bleeding scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer.
Measured: During the surgical procedure and 1 day after treatment
Postoperative Pain
Postoperative pain is assessed using a 10-cm Visual Analogue Scale (VAS), where 0 cm represents no pain and 10.0 cm represents unbearable pain. Pain intensity is categorized as follows: 0 = no pain; 0.1-3.0 cm = mild pain; 3.1-6.0 cm = moderate pain; and 6.1-10.0 cm = severe pain. VAS scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer.
Measured: 1, 3, and 7 days after treatment
Gingival Epithelialization
Epithelialization of the treated gingival surface is clinically assessed based on the presence and extent of epithelial coverage. Epithelialization is compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer.
Measured: 3 and 7 days after treatment
Patient Satisfaction
Patient satisfaction with the gingival esthetic treatment outcome is assessed using a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Measured: 6 months after treatment
Number of Gingival Units With Residual or Recurrent Pigmentation
Gingival Units With Residual or Recurrent Pigmentation The number of gingival units showing residual or recurrent melanin pigmentation is recorded for each treatment modality during follow-up.
Measured: 1 month, 3 months, and 6 months after treatment
Willingness to Repeat Gingival Esthetic Treatment
Repeat Gingival Esthetic Treatment Participants are asked whether they would be willing to undergo the gingival esthetic procedure again if needed. Responses are recorded as Yes or No.
Measured: 6 months after treatment
Preferred Treatment Modality
Participants are asked which treatment modality they would prefer if gingival depigmentation were repeated: diode laser or ceramic soft tissue trimmer.
Measured: 6 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 posted25 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiologic Gingival Melanin 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
- Model description
- This study uses a randomized split-mouth design. Each participant receives both interventions in paired contralateral gingival regions. One region is randomly assigned to treatment with a 940 nm diode laser, while the contralateral region is treated with a ceramic soft tissue trimmer.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huy Gia Ho, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841119
- Sponsor's protocol ID
- 2669/QĐ-ĐHYD
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gingival Depigmentation Using a 940 nm GaAlAs Diode Laser and Ceramic Bur: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07841119
- Acronym / sponsor ID
- 2669/QĐ-ĐHYD
- Keywords
- Gingival depigmentation, Gingival melanin pigmentation, Diode laser, Ceramic soft tissue trimmer, Split-mouth randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 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.
This randomized split-mouth clinical trial will compare the effectiveness of a 940 nm GaAlAs diode laser and a ceramic soft tissue trimmer for the treatment of physiologic gingival melanin pigmentation. Each participant will receive both treatment modalities in separate gingival regions according to a randomized allocation. Changes in gingival pigmentation will be evaluated using clinical pigmentation indices and digital image analysis. Participants will be followed at 1, 3, and 6 months after treatment to assess pigmentation reduction and repigmentation.
Detailed description
Physiologic gingival melanin pigmentation may affect smile aesthetics and may be treated using several depigmentation techniques. This study is designed as a randomized split-mouth clinical trial comparing a 940 nm GaAlAs diode laser (Epic X, BIOLASE) with a ceramic soft tissue trimmer for gingival depigmentation.
Eligible participants with physiologic gingival melanin pigmentation will receive both interventions in paired gingival regions. Treatment allocation will be randomized. Clinical and photographic assessments will be performed at baseline and during follow-up visits at 1, 3, and 6 months. Gingival pigmentation will be evaluated based on pigmentation intensity and the extent of pigmented gingival area. The study will also assess the persistence or recurrence of pigmentation during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized split-mouth design. Each participant receives both interventions in paired contralateral gingival regions. One region is randomly assigned to treatment with a 940 nm diode laser, while the contralateral region is treated with a ceramic soft tissue trimmer.
| Arm | Type | Receives |
|---|---|---|
| Laser group | Experimental | Device: 940 nm GaAlAs Diode LaserGingival depigmentation is performed in one randomly assigned gingival region using a 940 nm GaAlAs diode laser (EpicX, Biolase). |
| Ceramic Bur Group | Active comparator | Device: Ceramic Soft Tissue TrimmerGingival depigmentation is performed in the contralateral gingival region using a ceramic soft tissue trimmer (NTI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older.
- Periodontal health, with gingival index (GI) ≤1, bleeding on probing (BOP) ≤10%, probing depths ≤3 mm, and no periodontitis.
- Thick gingival phenotype with moderate to severe physiologic melanin pigmentation, corresponding to DOPI scores of 2-3, affecting the facial gingiva of the anterior and premolar regions bilaterally.
- Good oral hygiene, with plaque index (PI) ≤1 and calculus index (CI) ≤1.
Key exclusion criteria (7 listed)
- Thin gingival phenotype at the treatment sites.
- Uncontrolled systemic diseases, including cardiovascular disease, hypertension, or diabetes mellitus.
- Pregnancy or lactation.
- Use of medications or presence of conditions affecting hemostasis or wound healing.
- Oral pigmentation attributable to causes other than physiologic melanin pigmentation, including metallic pigmentation, amalgam tattoo, traumatic tattoo, or pigmentation associated with malignant conditions.
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 |
|---|---|---|
| 940 nm GaAlAs Diode LaserAlso: EPIC X (BIOLASE)Gingival depigmentation is performed using a 940 nm GaAlAs diode laser (EPIC X, BIOLASE) according to the study protocol. | Device | Laser group |
| Ceramic Soft Tissue TrimmerAlso: NTI Tissue TrimmerGingival depigmentation is performed using a ceramic soft tissue trimmer (NTI) according to the study protocol. | Device | Ceramic Bur Group |
Primary outcome
Change in Dummett Oral Pigmentation Index (DOPI)
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Gingival pigmentation intensity is assessed using the Dummett Oral Pigmentation Index (DOPI), scored from 0 to 3: score 0 = no clinical pigmentation, with pink gingiva; score 1 = mild pigmentation, characterized by light-brown gingiva; score 2 = moderate pigmentation, characterized by medium-brown or mixed pink and brown gingiva; and score 3 = heavy pigmentation, characterized by deep-brown or bluish-black gingiva. Higher scores indicate greater gingival pigmentation intensity. DOPI scores are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer over follow-up.
Change in Pigmented Gingival Area
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
The pigmented gingival area is quantified from standardized clinical photographs using digital image analysis and expressed as the percentage of the total gingival area showing melanin pigmentation. Changes are compared between the two treatment modalities over follow-up.
Extent of Gingival Pigmentation According to the Ponnaiyan Classification
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
The extent and distribution of gingival melanin pigmentation are assessed according to the Ponnaiyan classification (2013), which categorizes pigmentation into six types based on the gingival areas involved: Type I, pigmentation limited to the attached gingiva; Type II, pigmentation involving the attached gingiva and interdental papillae; Type III, pigmentation involving the attached gingiva, marginal gingiva, and interdental papillae; Type IV, pigmentation limited to the marginal gingiva; Type V, pigmentation limited to the interdental papillae; and Type VI, pigmentation involving the marginal gingiva and interdental papillae. Changes in Ponnaiyan classification are compared between gingival regions treated with the 940 nm diode laser and the ceramic soft tissue trimmer during follow-up.
8 secondary outcomes
Surgical Procedure Time
Time frame: During the surgical procedure
Perioperative Bleeding
Time frame: During the surgical procedure and 1 day after treatment
Postoperative Pain
Time frame: 1, 3, and 7 days after treatment
Gingival Epithelialization
Time frame: 3 and 7 days after treatment
Patient Satisfaction
Time frame: 6 months after treatment
Number of Gingival Units With Residual or Recurrent Pigmentation
Time frame: 1 month, 3 months, and 6 months after treatment
Willingness to Repeat Gingival Esthetic Treatment
Time frame: 6 months after treatment
Preferred Treatment Modality
Time frame: 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 940 nm GaAlAs Diode Laser and Ceramic Soft Tissue Trimmer in people with Physiologic Gingival Melanin Pigmentation, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 7 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: opening soon, as of the sponsor's last update on 25 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huy Gia Ho, DDS (+84942560496, ghuygl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dummett Oral Pigmentation Index (DOPI) (time frame: Baseline, 1 month, 3 months, and 6 months after treatment). 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?
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 25 Sep 2026.