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Microneedling with vitamin C application for the treatment of gum melanin hyperpigmentation

Microneedling with Topical Vitamin C versus Scalpel Technique for the Esthetic Management of Physiologic Gingival Melanin Hyperpigmentation: A Randomized Controlled Clinical Trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066602
Enrollment
26
Registered
2024-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: K068- Other specified disorders of gingiva and edentulous alveolar ridge

Interventions

Intervention1: Microneedling with topical vitamin C: Dermapen device(Model M8) with 16 pins stainless steel needle cartridge attachment, will be used for microneedling pigmented gingiva. The depth of

Sponsors

Dr Anika Dawar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Physiologic gingival hyperpigmentation as diagnosed by recent classification of Periodontal and Peri-implant diseases 2017 2.Physiologic gingival hyperpigmentation in anterior aesthetic zone of maxillary gingiva 3. Adults seeking gingival depigmentation treatment for esthetic concerns. 4. Available/Willing to come for 4 subsequent visits and follow-ups 5.Adequate oral hygiene 6.No systemic illness

Exclusion criteria

Exclusion criteria: 1. Pathologic or drug-induced gingival pigmentation 2. Physiologic gingival pigmentation only in mandibular gingiva 3. Any systemic disease causing gingival hyperpigmentation 4. Smokers 5. Pregnant or lactating females 6. Patients with periodontal disease 7. Patients taking vitamin C supplements 7. Patients with hypersensitivity to ascorbic acid 8.Patient taking vitamin C supplements

Design outcomes

Primary

MeasureTime frame
Change in gingival pigmentation intensity score( Dummett- Gupta oral pigmentation index) 0: no clinical pigmentation(pink tissue),1: mild clinical pigmentation(mild light brown color), 2:moderate clinical pigmentation (medium brown or mixed pink and brown coloration,3: heavy clinical pigmentation(deep brown or blue-black tissue).Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment

Secondary

MeasureTime frame
Change in gingival pigmentation extent score( Gingival pigmentation index) 0: Absence,1: spots of brown or black, 2: brown or black patches but not diffuse,3: diffuse brown or black pigmentationTimepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in Gingival pigmented area on digital photographs Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in Gingival Luminescence(L value: 0 to 100) on digital photographs Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in gingival melanin score(0-100)Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Change in Gingival thickness Timepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Correlation of change in gingival melanin score with skin melanin scoreTimepoint: Baseline and follow-up visits at 1,3,6 months after completion of treatment;Difference in patient reported color improvement and overall treatment satisfaction scoresTimepoint: Follow-up visits at 1,3,6 months after completion of treatment;Difference in patient reported Pain, Itching, Discomfort VAS scoresTimepoint: From the day of procedure upto 7 days

Countries

India

Contacts

Public ContactDr Anika Dawar

All India Institute of medical Sciences, New Delhi

anika_doc@yahoo.com9953270897

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 3, 2026