Gingival Pigmentation Intensity and Distribution Among Egyptians

NCT07316205 | Completed

• 1 other identifier: Gingival pigmentation
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the distribution, intensity and extension of gingival hyperpigmentation among a sample of Egyptian population.

Conditions

Gingiva Disorder

Keywords

gingival pigmentation; egyptians

Outcome Measures

Primary Outcomes (2)

• pigmentation distribution

  to evaluate distribution of gingival pigmentation using Hedin melanin index and de Krom classification Hedin melanin index: Used for evaluation of the distribution of pigmentation in the gingiva. It is scored as 0= absence of gingival pigmentation. 1. One or two isolated units of interdental papillae exhibit pigmentation. 2. Three or more distinct units of interdental papillae exhibit pigmentation. 3. continuous band of pigmented gingiva of short length. 4 = a broad band of continuous pigmented gingiva situated between the canines. de Krom classification: The de Krom classification has been invented to determine the distribution of pigmentation as follows: * Category 1: A wide band of pigmentation entirely encircles the dentition, exhibiting a distinct apical contour. The mucosa is pink above the mucogingival junction. The color of the gingiva may range from dark to light brown. The band is symmetrical, and its color is uniform. * Category 2: A narrow band of non-pigment

  baseline

• pigmentation intensity

  by using Dummet Oral Pigmentation Index (DOPI) This was used to evaluate the intensity of gingival pigmentation as follows: 0= Absence of clinical pigmentation (pink-colored gingiva) 1. Mild clinical pigmentation (light brown color) 2. Moderate clinical pigmentation (medium brown or a combination of pink and brown color) 3 = Significant clinical pigmentation (dark brown or bluish-black color)

  baseline

Study Arms (1)

Patients

Evaluate the gingival pigmentation in the anterior zone using the Oral pigmentation index, Hedin melanin index and de Krom classification

Other: Evaluatation of the gingival pigmentation intensty and distribution

Interventions

Evaluatation of the gingival pigmentation intensty and distribution OTHER

After taking history \& clinical examination, three examiners will evaluate the gingival pigmentation in the anterior zone using the following indices: Clinical evaluation: Oral pigmentation index (DOPI) Dummet et al.,1967: This index of oral pigmentation is the commonly used index due to its simplicity and ease of use measure hyperpigmentation intensity. The scores are as follows: * No clinical pigmentation (pink-colored gingiva) * Mild clinical pigmentation (mild light brown color) * Moderate clinical pigmentation (medium brown or mixed pink and brown color) * Heavy clinical pigmentation (deep brown or bluish black color) Hedin melanin index (Hedin.,1977) for distribution of the pigmentation in the gingiva. It is scored as: 0 = no gingival pigmentation. 1. = one or two solitary units of interdental papillae are pigmented. 2. = more than 3 separate units of interdental papillae are pigmented. 3. = 1 short continuous band of pigmented

Patients

Eligibility Criteria

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

Study Population

population of any age except children that will seeking treatment at the dental clinics

You may qualify if:

• Patients were free from any systemic disease as evidenced by Burkett's oral medicine health history questionnaire Greenberg et al.,2012.
• Patients with physiologic gingival hyperpigmentation in the aesthetic zone.

You may not qualify if:

• Smokers.
• Pregnant and lactating women.
• Drugs intake which associates with gingival melanin pigmentation such as Antimalarials drugs, phenothiazines and oral contraceptives.
• Pathologies that cause gingival pigmentation (e.g.: Addison's disease, Albright's syndrome, Kaposi sarcoma)
• Patients with periodontal disease.
• Physical or mental impairment.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 5, 2026
• Study Start: January 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)