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

NCT05453890 | Completed

• 1 other identifier: POD 1
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Pigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Age of the participant associated risk factors

  Up to 30 weeks

• Gender of the participant

  Up to 30 weeks

• Occupation of the participant

  Up to 30 weeks

• Type of smoking

  Up to 30 weeks

• Frequency of smoking

  Up to 30 weeks

Study Arms (1)

A sample of adult egyptian population

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11271, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 12, 2022
• Study Start: October 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: June 15, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

EG (1)