NCT07810101

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
6mo left

Started Sep 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

August 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 22, 2026

Last Update Submit

September 8, 2026

Conditions

Gingival PigmentationGingiival Hyperpigmentation

Keywords

liquid nitrogen and ascorbic acid in gingival depigentationLiquid Nitrogenascorbic acid

Outcome Measures

Primary Outcomes (2)

  • Clinical severity of gingival pigmentation

    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).

    3 month follow up

  • Clinical severity of gingival pigmentation

    DOPI index of gingival pigmentation

    3 month follow up

Secondary Outcomes (1)

  • Histologic assessment of the melanin forming cells

    3 month follow up

Study Arms (3)

Patients will receive topical application of ascorbic acid

ACTIVE COMPARATOR
Drug: Topical application of ascorbic acid for treatment of gingival pigmentation

Patients will receive topical application of liquid nitrogen

ACTIVE COMPARATOR
Combination Product: Topical application of liquid nitrogen for treatment of gingival pigmentation

Patients will receive surgical depigmentation (conventional technique)

ACTIVE COMPARATOR
Procedure: Treatment of gingival pigmentation by surgical technique

Interventions

Topical application of liquid nitrogen for treatment of gingival pigmentationCOMBINATION_PRODUCT

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

Patients will receive topical application of liquid nitrogen
Topical application of ascorbic acid for treatment of gingival pigmentationDRUG

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

Patients will receive topical application of ascorbic acid
Treatment of gingival pigmentation by surgical techniquePROCEDURE

conventional technique for treatment of gingival pigmentation

Patients will receive surgical depigmentation (conventional technique)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dental medicine, Alazhar university, Assiut branch

Asyut, Asyut Governorate, 71511, Egypt

Location

Related Publications (2)

  • Kamboj S, Salaria SK. Efficacy of liquid nitrogen and electrocautery assisted gingival depigmentation in term of patient's perception, histological wound healing - A randomized triple blind clinical trial. J Indian Soc Periodontol. 2020 Mar-Apr;24(2):135-144. doi: 10.4103/jisp.jisp_438_19. Epub 2020 Mar 2.

    PMID: 32189841BACKGROUND

  • El-Mofty M, Elkot S, Ghoneim A, Yossri D, Ezzatt OM. Vitamin C mesotherapy versus topical application for gingival hyperpigmentation: a clinical and histopathological study. Clin Oral Investig. 2021 Dec;25(12):6881-6889. doi: 10.1007/s00784-021-03978-6. Epub 2021 May 8.

    PMID: 33966113BACKGROUND

Study Officials

  • Ibrahim Hammad Ibrahim, assistant professor

    ALAzhar U

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)