Gingival Hyperpigmentation Treatment

NCT07595705 | Recruiting Phase 2

• 1 other identifier: IRB00012891#159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel

Conditions

Gingival Pigmentation; Depigmentation; Vitamin C; Glutathione

Keywords

depigmentation; vit c; glutathione; gingival depigmentation

Outcome Measures

Primary Outcomes (2)

• Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)

  Degree of gingival pigmentation 0: no pigmentation 1. solitary unit (s) of pigmentation in papillary gingiva without extension between neighboring solitary units 2. formation of continuous ribbon extending from neighboring solitary units)

  baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month

• Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)

  Score 0: absence Score 1: spots of brown to black Score 2: brown to black patches but not diffuse Score 3: diffuse brown to black pigmentation

  The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.

Secondary Outcomes (3)

• Pain score

  visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)

• Itching

  visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)

• Patient satisfaction

  At the end of the follow up period ( 9 months)

Study Arms (2)

Arm1:(Vit C & glutathione injection)

EXPERIMENTAL

The site of interest will be anesthetized using topical anesthetic agent (lignocaine gel or xylocaine gel). Infiltration anesthesia will be recommended during the first injection visit. Intraepidermal injection of 1-1.5 ml of vitamin C and glutathione will be performed. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (50 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C \& glutathione will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Maximum 0.1 ml of injection is recommended for each point with 2-3 mm apart. The same dose will be repeated once per week for maximum 4 visits till no further color improvement gained.

Drug: Vitamin c and glutathione

ATM 2: surgical depigmentation

ACTIVE COMPARATOR

Using a 15c blade an epithelial layer and part of connective tissue will be removed till the pigmentation disappears with ultra care not to expose the bone. The marginal and interdental papillary tissues remain critical regions, fortunately, they are not deeply pigmented. Periodontal dressing is recommended for minimal 7 days postoperative. Patients will be instructed to avoid the mechanical trauma to the treated sites. Patients will be administering an analgesic (Ibuprofen 400 mg) to be used as needed. Following each injection visit, the patients will be asked to abstain from mechanical oral hygiene procedures in relation to the target region for the day of procedure only. Plain tooth pastes (Colgate toothpaste) with anti- inflammatory mouthwash (Citrolin mouth, Pharco Company, Egypt) were recommended.

Procedure: Surgical depigmentation

Interventions

Vitamin c and glutathione DRUG

Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)

Arm1:(Vit C & glutathione injection)

Surgical depigmentation PROCEDURE

Removal of gingival pigmentation by scalpel

ATM 2: surgical depigmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:
• Score0:absence of pigmentation
• Score1:spotsofbrowntoblackcolororpigments
• Score2:browntoblackpatchesbutnotdiffusepigmentation
• Score3:diffuse brown to black pigmentation,marginal,and attached.
• Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:
• above 18yrs
• systemically free
• physiologic gingival hyperpigmentation related to esthetic region
• well maintained oral hygiene and willing to undergo minor surgical procedures

You may not qualify if:

• systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
• pregnant and lactating mothers
• usage of chlorhexidine or povidone iodine
• Local causes (smoking)
• periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
• non compliant patients

Sponsors & Collaborators

• Cairo University: lead
• Fayoum University: collaborator

Study Sites (1)

Faculty of Dentistry

Al Fayyum, Faiyum Governorate, 63511, Egypt

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Ascorbic Acid; Glutathione

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nourhan A Abdullah, Phd

  Lecturer at faculty of dentistry, Fayoum university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nourhan A Abdelkhalek

CONTACT

01005802478; naa14@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 1. group 1 will be treated with conventional scalpel surgical depigmentation 2. group 2 will be treated with non-surgical intra-epidermal injection of vitamin C \& glutathione depigmentation. the following clinical measurements will be recorded. 1. The clinical assessment of the degree of gingival pigmentation will be performed using two different indices; * Takashi index * Gingival pigmentation index regular digital photographs which will be taken pre-operative, and post-operatively after 1, 3, 6 and 9 months. 2. Pain and itching will be reported by the patient after the surgical procedure and following each injection visit using visual analogue scale (VAS) at 24 hours 3. Patient satisfaction

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

EG (1)