The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population.

The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population: A Cross Sectional Study.

This observational cross-sectional study aims at determining the prevalence of gingival pigmentation among a sample of adult Egyptian patients attending the diagnostic centre at Faculty of Dentistry, Cairo University and identifying its association with other risk factors.

Study Overview

• Status: Completed
• Conditions: Gingival Pigmentation

Detailed Description

• Dental patients will be recruited in a consecutive manner from the diagnostic center, Faculty of Dentistry, Cairo University.
• Medical history will be taken and patients with certain diseases as Addison's disease, Albright's syndrome, Hereditary hemorrhagic telangiectasia, and HIV-associated melanosis or under certain drugs as ACTH, Antimalarial drugs, and Chemotherapeutic agent-busulfan that induce gingival pigmentation will be excluded from the study.
• Patients who met the inclusion criteria will be subjected to thorough oral examination and a full questionnaire will be filled for each patient. Before filling the questionnaire, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received.
• During examining patients, any patient found with suspicious gingival pigmentation, whether the degree of pigmentation, texture, size, or any clinical signs of malignancy, will be referred to the Oral Medicine department for a thorough oral and lymph nodes examination, and biopsy taking if needed. Also, any other suspicious oral lesion noticed will be treated the same way, and a close follow-up for the patient will be done to ensure that the he/she has gone through all possible examination protocols to exclude any possibility of malignancy or abnormal condition that needs intervention.
• During oral examination of included patients, those will be found to have gingival pigmentation will be classified according to the gingival pigmentation index.
• Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal.
• The Questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
• The Questionnaire will include a section for information about age, gender, occupation, place of birth and current residential area.
• Detailed information about smoking type (cigarette, shisha, Vape, IQOS, or others), Smoking Frequency, Smoking duration (no. of years) will be gathered
• The degree of satisfaction or dissatisfaction with gingival pigmentation, and the willingness to do a surgical or laser procedure to change it will be evaluated by VAS score.
• Conventional oral examination will be held on a dental unit using the light of the unit.

• Study Type: Observational
• Enrollment (Actual): 374

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11271
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A sample of adult Egyptian patients attending the diagnostic centre at Faculty of Dentistry, Cairo University and identifying its association with other risk factors.

Description

Inclusion Criteria:

• Adult patients whose age is 18 years old and above.
• Patient consulting in the diagnostic centre, Faculty of Dentistry, Cairo University.
• Provide informed consent.

Exclusion Criteria:

• Systemic diseases and syndromes known to be associated with oral melanin pigmentation, such as Addison's disease, Albright's syndrome, Hereditary hemorrhagic telangiectasia, and HIV-associated melanosis (Peeran et al 2014).
• Patients taking certain drugs that predispose to drug-induced melanin pigmentation, such as: ACTH, Antimalarial drugs, and Chemotherapeutic agent-busulfan (Peeran et al 2014).
• Tattoos of the oral mucosa
• Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.
• Patients diagnosed with psychiatric problems.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
A sample of adult egyptian population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of gingival pigmentation	Gingival Pigmentation Index which classified pigmentation into 4 scores according to the position and extent of the gingival pigments: Score 0: Absence of pigmentation; Score 1: Spots of brown to black color or pigments.; Score 2: Brown to black patches but not diffuse pigmentation; Score 3: Diffuse brown to black pigmentation, marginal, and attached	Up to 30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of the participant associated risk factors	Age in years	Up to 30 weeks
Gender of the participant	Male or female	Up to 30 weeks
Occupation of the participant	Certain occupations may be a possible risk factor	Up to 30 weeks
Type of smoking	Cigarette, shisha, Vape, IQOS,… etc. certain types may be of variable risk factor	Up to 30 weeks
Frequency of smoking	Number of Cigarettes/day, In case of other types: daily, weekly, twice weekly, monthly	Up to 30 weeks
Duration of smoking	In years	Up to 30 weeks
Place of birth	City of birth	Up to 30 weeks
Current area of residence	City of residence	Up to 30 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: POD 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No