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Comparison of Microneedling Technique with Tetrafluoroethane, Topical Ascorbic Acid (Vitmain C), and Diode LASER for gum depigmentation

Comparative Evaluation of Microneedling Technique with Tetrafluoroethane, Topical Ascorbic Acid, and Diode LASER for Gingival Depigmentation: A Randomized Clinical Trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088443
Enrollment
33
Registered
2025-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: K069- Disorder of gingiva and edentulousalveolar ridge, unspecified

Interventions

Intervention1: Microneedling with tetrafluoroethane: Microneedling to be done under local infiltration anesthesia. Then tetrafluoroethane is applied in cotton and applied on the hyperpigmented gums f

Sponsors

Dr. Anwesha Basu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Systematically healthy individuals between above mentioned ages. 2) Plaque index score of 1 and gingival index score of 1. 3) More than 1mm gingival thickness. 4) Patient score of 1 to 2 according to Gingival Pigmentation Index by Peeran et al (2014). 5) Patient score of Class 1 to 2 of the Liebart and Deruelle Smile Line classification (2004). 6) Patients who agree to participate in the study by signing the informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients on antibiotics or anti-inflammatory medicines. 2) History of periodontal surgery within the last 6 months. 3) Mothers who are pregnant or nursing. 4) Patients with systematically compromised health. 5) Patients who are not compliant with the procedure. 6) Patients having side effects from tetrafluoroethane and vitamin C during the patch test done prior to starting the procedure. 7) Patients with a history of cold urticaria.

Design outcomes

Primary

MeasureTime frame
Measurement of gingival thickness and intensity of gingival pigmentation.Timepoint: Baseline, one month, six months, twelve months.

Secondary

MeasureTime frame
Patient perception of gingival aesthetics, and patient satisfaction.Timepoint: Baseline, twelve months.

Countries

India

Contacts

Public ContactDr Anwesha Basu

Manipal College of Dental Sciences, Mangalore

deepa.gkamath@manipal.edu9448454788

Outcome results

None listed

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