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Enrolling by invitation

NCT Number: NCT07810101

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

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.

Enrolling by invitation

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of dental medicine, Alazhar university, Assiut branch

Asyut, Asyut Governorate, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical application of ascorbic acid for treatment of gingival pigmentation

Drug

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

Topical application of liquid nitrogen for treatment of gingival pigmentation

Combination Product

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

Treatment of gingival pigmentation by surgical technique

Procedure

conventional technique for treatment of gingival pigmentation

Primary outcomes

  1. Clinical severity of gingival pigmentation

    Time frame: 3 month follow up

    DOPI 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).

  2. Clinical severity of gingival pigmentation

    Time frame: 3 month follow up

    DOPI index of gingival pigmentation

Secondary outcomes

  1. Histologic assessment of the melanin forming cells

    Time frame: 3 month follow up

    Histologic assessment of the melanin forming cells by Hematoxylin and Eosin (H&E) stain to veiw the melanocytes and the melanin pigentation in epithelium.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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