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Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation

Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation

Status
Enrolling by invitation
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07810101
Enrollment
30
Registered
2026-09-09
Start date
2026-09-01
Completion date
2027-04-01
Last updated
2026-09-09

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

Conditions

Gingiival Hyperpigmentation, Gingival Pigmentation

Keywords

liquid nitrogen and ascorbic acid in gingival depigentation, Liquid Nitrogen, ascorbic acid

Brief summary

Aim of study The present study will be designed to evaluate the clinical and histomorphometric outcomes of using topical liquid nitrogen and topical ascorbic acid in gingival depigmentation. Primary outcome: • Clinical severity and extension of gingival pigmentation. Secondary outcome: • Histologic assessment of the melanin forming cells.

Detailed description

Gingival hyperpigmentation is caused by excessive deposition of melanin in the basal and parabasal cell layers of the epithelium, it's mainly physiological due to the production of melanin. One of the factors that determines the colour of the gingiva is the amount of melanin pigment in the gingival epithelium. The intensity of melanin pigmentation differs from one person to another, and it is prevalent among all ethnicities. Gingival melanin pigmentation may cause esthetic concerns, even if no serious medical problem is present. Gingival depigmentation can be defined as a periodontal plastic surgical procedure whereby the gingival hyperpigmentation is removed or reduced by various techniques. Depigmentation is not a clinical indication but a treatment of choice where esthetics is a concern and is desired by the patients. A variety of depigmentation techniques can be classified into the following groups: surgical methods (Conventional techniques) as gingival abrasion and split thickness epithelial excision/scalpel, surgical technique/surgical stripping, electrosurgery, lasers, cryosurgery with liquid nitrogen, radiosurgery, and chemical methods using agents such as alcohols, phenols, and ascorbic acid. Vitamin C, known as ascorbic acid, is used as a treatment modality in depigmentation of hyperpigmented spots on the skin and gingiva by inhibition of tyrosinase enzyme causing melanin biosynthesis suppression. Vitamin C interacts with the copper (Cu) ions at the tyrosinase active site and inhibits the action of the enzyme tyrosinase, thereby reducing melanin formation. It also acts on the perifollicular pigment. However, it is an unstable compound. Therefore, it is used in combination with soy and liquorice for depigmentation in dermatology. Advantages of cryotherapy include being a bloodless treatment, very low incidence of secondary infection and with a relative lack of scarring and pain. It provides a very good esthetic result and may be either the first choice or an alternative option to conventional surgery. Cryotherapy with liquid nitrogen is the deliberate destruction of tissue by application of extreme cold that leads to freezing of pigmented cells.

Interventions

DRUGTopical application of ascorbic acid for treatment of gingival pigmentation

topical application of ascorbic acid (non surgical technique ) for treatment of gingival pigmentation

COMBINATION_PRODUCTTopical application of liquid nitrogen for treatment of gingival pigmentation

Topical application of liquid nitrogen (non surgical technique ) for treatment of gingival pigmentation

PROCEDURETreatment of gingival pigmentation by surgical technique

conventional technique for treatment of gingival pigmentation

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Individuals with mild-to-severe anterior melanin gingival pigmentation in the anterior portion of the upper and lower gingiva according to Dummet's classification will be involved. * The patients included in this study will be Type 1 individuals according to American Society of Anesthesiology . * The age of the patients ranges between 18 and 40 years.

Exclusion criteria

* smoker patients * pregnant and lactating women * patients with any systemic disease that may induce the production of melanin * patients with periodontal disease, non vital anterior teeth * patients with known hypersensitivity to ascorbic acid * patients who had previous depigmentation procedures.

Design outcomes

Primary

MeasureTime frameDescription
Clinical severity of gingival pigmentation3 month follow upDOPI index of gingival pigmentation (Dummett-Gupta Oral Pigmentation Index) sores the intensity of gingival pigmentation with scores ranges from 0 to 3, 0 = no pigmentation (pink gingiva) and 3 = heavy pigmentation (deep brown / blue - black gingiva).

Secondary

MeasureTime frameDescription
Histologic assessment of the melanin forming cells3 month follow upHistologic assessment of the melanin forming cells by Hematoxylin and Eosin (H\&E) stain to veiw the melanocytes and the melanin pigentation in epithelium.

Countries

Egypt

Contacts

STUDY_DIRECTORIbrahim Hammad Ibrahim, assistant professor

ALAzhar U

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026