Comparison of two different laser techniques in the removal of gingival pigmentation

Laser-assisted physiologic gingival melanin depigmentation: surgical technique versus selective photo thermolysis (randomized comparative clinical trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68390623

Enrollment

Registered

2023-06-29

Start date

2022-09-03

Completion date

Unknown

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiologic gingival melanin pigmentation Oral Health

Interventions

The study is designed to compare the effectiveness of both the ablative technique (surgical technique) of diode 980 nm and carbon dioxide laser (10600 nm), and the non-ablative technique (selective ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients exhibiting physiologic gingival melanin pigmentation of score 2 or more according to Dummet et al. 2. Aged 18-45 years

Exclusion criteria

Exclusion criteria: 1. Pathologic hyperpigmentation 2. Patients with periodontitis or acute gingivitis 3. Taking medications that may induce gingival pigmentations such as antimalarial agents, and tricyclic antidepressants 4. Systemic diseases that could affect tissue healing (e.g autoimmune diseases) 5. Pregnancy and lactation 6. Current smokers 7. Previous mucogingival surgery at the region to be treated

Design outcomes

Primary

Measure	Time frame
Gingival pigmentation recurrence measured using Dummet et al index for gingival pigmentation color and Takashi index for gingival pigmentation extension after 1, 3, 6, and 9 months	—

Secondary

Measure	Time frame
1. Bleeding assessed using a bleeding index (0 to 3) directly after surgery 2. Healing assessed using a healing index 10 days and 1 month postoperatively 3. Procedure duration recorded in minutes for each jaw (this is the laser surgery duration which will be recorded after local anesthesia for each jaw separately), during the clinical procedure 4. Procedure difficulty assessed by the researcher directly after the procedure (laser surgery) 5. Gingival appearance assessed using a gingival appearance score at 1, 3, 6, and 9 months postoperatively 6. Pain, edema, and discomfort evaluated using a self-modified McGill questionnaire immediately after the procedure, 1 day, and 10 days postoperatively 7. Patient satisfaction assessed using questionnaire at the end of follow-up sessions	—

Measure

Time frame

1. Bleeding assessed using a bleeding index (0 to 3) directly after surgery 2. Healing assessed using a healing index 10 days and 1 month postoperatively 3. Procedure duration recorded in minutes for each jaw (this is the laser surgery duration which will be recorded after local anesthesia for each jaw separately), during the clinical procedure 4. Procedure difficulty assessed by the researcher directly after the procedure (laser surgery) 5. Gingival appearance assessed using a gingival appearance score at 1, 3, 6, and 9 months postoperatively 6. Pain, edema, and discomfort evaluated using a self-modified McGill questionnaire immediately after the procedure, 1 day, and 10 days postoperatively 7. Patient satisfaction assessed using questionnaire at the end of follow-up sessions

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Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026