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Comparative Efficacy of Microneedling and Mesotherapy with Ascorbic Acid in Gingival Depigmentation: A Split- Mouth Randomized Clinical and Histopathological Trial

Comparative Efficacy of Microneedling and Mesotherapy with Ascorbic Acid in Gingival Depigmentation: A Split- Mouth Clinical and Histopathological Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250627003
Enrollment
40
Registered
2025-06-27
Start date
2025-06-25
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

The degree of gingival pigmentation will be evaluated using the Dummett-Gupta Oral Pigmentation Index (DOPI), Hedin melanin index (HMI), - A Visual Analogue Scale (VAS), The level of patient&#039

Interventions

Microneedling will be performed using a Dermapen device, with a solution of ascorbic acid 1,000 mg / mL mixed with saline applied to the gingiva for 10 minutes. The Dermapen will be positioned perpend
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Microneedling with ascorbic acid,Mesotherapy with ascorbic acid

Sponsors

Hospital of Stomatology of Sanaa University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Male and female, age ranges of 18 to 35 years. 2. Individuals with moderate to severe anterior gingival pigmentation. 3. Good general health without any systemic diseases.

Exclusion criteria

Exclusion criteria: 1. Individuals with periodontal disease and with a thin gingival phenotype. 2. Individuals who smoke or those who have tobacco related habits. 3. Pregnant or lactating women. 4. Non vital anterior teeth, active caries and prosthesis. 5. Hypersensitivity to ascorbic acid. 6. Who had previous depigmentation procedure. 7. Use of medications that promote gingival pigmentation.

Design outcomes

Primary

MeasureTime frame
Gingival depigmentation and number of melanocyte per field Baseline, third month, sixth month Measured by (DOPI), (HMI), VAS, Likert and histopathologial examination

Secondary

MeasureTime frame
histopathological examination baseline, sixth month Two tissue samples will be obtained from each patient at baseline and 6 months after treatment by the same operator for histological analysis.

Countries

Yemen

Contacts

Public ContactWardah Al Otab

Stomatology hospital of Sanaa universty

wardah.al.otab@gmail.com00967776626270

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026