Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
940 nm GaAlAs Diode Laser
DeviceGingival depigmentation is performed using a 940 nm GaAlAs diode laser (EPIC X, BIOLASE) according to the study protocol.
Ceramic Soft Tissue Trimmer
DeviceGingival depigmentation is performed using a ceramic soft tissue trimmer (NTI) according to the study protocol.
Treatment groups
17 Participants
are divided into 2 treatment groupsGroup A: Laser groupExperimental treatment 1 intervention
Group B: Ceramic Bur GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 1 month, 3 months, and 6 months after treatment2
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.
Time frame
Baseline, 1 month, 3 months, and 6 months after treatment3
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.
Time frame
Baseline, 1 month, 3 months, and 6 months after treatmentSecondary outcomes
1
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.
Time frame
During the surgical procedure2
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.
Time frame
During the surgical procedure and 1 day after treatment3
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.
Time frame
1, 3, and 7 days after treatment4
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.
Time frame
3 and 7 days after treatmentSponsors and contacts
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Source ClinicalTrials.gov
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