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

Gingival Pigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05453890
• Other study ID #: POD 1
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 374
• Est. completion date: June 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Pigmentation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

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