Gingiva DisorderNCT07316205
Gingival Pigmentation Intensity and Distribution Among Egyptians
An observational study of Gingiva Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the distribution, intensity and extension of gingival hyperpigmentation among a sample of Egyptian population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingiva Disorder
- What is being tested?
- Evaluatation of the gingival pigmentation intensty and distribution
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to 20 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: population of any age except children that will seeking treatment at the dental clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beyond Pink: Assessing Gingival Pigmentation in the Egyptian Population: A Cross-Sectional Study
The aim of the present study is to evaluate the distribution, intensity and extension of gingival hyperpigmentation among a sample of Egyptian population.
Read the detailed description
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):
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 for distribution of the pigmentation in the gingiva.
It is scored as:
0 = no gingival pigmentation.
- = one or two solitary units of interdental papillae are pigmented.
- = more than 3 separate units of interdental papillae are pigmented.
- = 1 short continuous band of pigmented gingiva.
- = one wideband continuous pigmented gingiva between the canines. The total scores of Hedin index of the mandible and maxilla will be obtained at baseline, one month, and six months after the depigmentation procedures. de Krom classification:
The de Krom classification will be conceived to assess pigmentation distribution. It includes six categories:
Category 1: Broad zone of pigmentation completely surrounds the dentition, displaying a clear apical contour. Apical to the mucogingival junction, the mucosa is pink. Gingival color can vary from dark to light brown. The zone is symmetric and the color uniform.
Category 2: Narrow zone of non-pigmented gingiva completely surrounds the teeth, that is, the marginal gingiva is pink. The remaining attached gingiva is as in Category 1, a broad zone of pig mentation. The zone is symmetric and the color uniform.
Category 3: Mucosa is completely pink, except for a thick or thin line of pigmentation at the level of the mucogingival junction. The pigmented zone is symmetric and the color uniform.
Category 4: Pigmentation is spread over the mucosa. It is asymmetric, patchy, and irregular. The color can be dark at one tooth and pink at the adjacent tooth.
Category 5: Mucosa is completely pink with the exception of a number of symmetric "islands" of pigmentation between anterior teeth. The patches are localized and dark, in contrast to the surrounding (pink) tissue. These patches do not extend to the gingiva. Category 6: Mucosa is completely pink and there are no signs of melanin pigmentation.
- Conditions
- Gingiva Disorder
- Being tested
- Evaluatation of the gingival pigmentation intensty and distribution
- Keywords
- gingival pigmentation, egyptians
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluatation of the gingival pigmentation intensty and distributionOther
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.
- = one or two solitary units of interdental papillae are pigmented.
- = more than 3 separate units of interdental papillae are pigmented.
- = 1 short continuous band of pigmented
| Study group | Role | What they receive |
|---|---|---|
| Patients | Evaluate the gingival pigmentation in the anterior zone using the Oral pigmentation index, Hedin melanin index and de Krom classification Receives: Other: Evaluatation of the gingival pigmentation intensty and distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- One or two isolated units of interdental papillae exhibit pigmentation.
- Three or more distinct units of interdental papillae exhibit pigmentation.
- 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
Measured: 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)
- Mild clinical pigmentation (light brown color)
- Moderate clinical pigmentation (medium brown or a combination of pink and brown color) 3 = Significant clinical pigmentation (dark brown or bluish-black color)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start20 Jan 2025
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingiva DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Alghriany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316205
- Sponsor's protocol ID
- Gingival pigmentation
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Pink: Assessing Gingival Pigmentation in the Egyptian Population: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07316205
- Acronym / sponsor ID
- Gingival pigmentation
- Conditions
- Gingiva Disorder
- Keywords
- gingival pigmentation, egyptians
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the distribution, intensity and extension of gingival hyperpigmentation among a sample of Egyptian population.
Detailed description
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):
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 for distribution of the pigmentation in the gingiva.
It is scored as:
0 = no gingival pigmentation.
- = one or two solitary units of interdental papillae are pigmented.
- = more than 3 separate units of interdental papillae are pigmented.
- = 1 short continuous band of pigmented gingiva.
- = one wideband continuous pigmented gingiva between the canines. The total scores of Hedin index of the mandible and maxilla will be obtained at baseline, one month, and six months after the depigmentation procedures. de Krom classification:
The de Krom classification will be conceived to assess pigmentation distribution. It includes six categories:
Category 1: Broad zone of pigmentation completely surrounds the dentition, displaying a clear apical contour. Apical to the mucogingival junction, the mucosa is pink. Gingival color can vary from dark to light brown. The zone is symmetric and the color uniform.
Category 2: Narrow zone of non-pigmented gingiva completely surrounds the teeth, that is, the marginal gingiva is pink. The remaining attached gingiva is as in Category 1, a broad zone of pig mentation. The zone is symmetric and the color uniform.
Category 3: Mucosa is completely pink, except for a thick or thin line of pigmentation at the level of the mucogingival junction. The pigmented zone is symmetric and the color uniform.
Category 4: Pigmentation is spread over the mucosa. It is asymmetric, patchy, and irregular. The color can be dark at one tooth and pink at the adjacent tooth.
Category 5: Mucosa is completely pink with the exception of a number of symmetric "islands" of pigmentation between anterior teeth. The patches are localized and dark, in contrast to the surrounding (pink) tissue. These patches do not extend to the gingiva. Category 6: Mucosa is completely pink and there are no signs of melanin pigmentation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Evaluatation of the gingival pigmentation intensty and distributionEvaluate the gingival pigmentation in the anterior zone using the Oral pigmentation index, Hedin melanin index and de Krom classification |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- population of any age except children that will seeking treatment at the dental clinics
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluatation of the gingival pigmentation intensty and distributionAfter 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 | Other | Patients |
Primary outcome
pigmentation distribution
Time frame: baseline
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
pigmentation intensity
Time frame: baseline
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Gingiva Disorder
Not yet recruiting
Spirulina Gel in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingiva Disorder, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pigmentation distribution (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.