Gingival PigmentationNCT05453890
The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population.
An observational study of Gingival Pigmentation, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation
- How many people
- 374 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 15 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients whose age is 18 years old and above.
- Patient consulting in the diagnostic centre, Faculty of Dentistry, Cairo University.
- Provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Pigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A sample of adult egyptian population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 weeks
Secondary outcomes (8)
Age of the participant associated risk factors
Age in years
Measured: Up to 30 weeks
Gender of the participant
Male or female
Measured: Up to 30 weeks
Occupation of the participant
Certain occupations may be a possible risk factor
Measured: Up to 30 weeks
Type of smoking
Cigarette, shisha, Vape, IQOS,… etc. certain types may be of variable risk factor
Measured: Up to 30 weeks
Frequency of smoking
Number of Cigarettes/day, In case of other types: daily, weekly, twice weekly, monthly
Measured: Up to 30 weeks
Duration of smoking
In years
Measured: Up to 30 weeks
Place of birth
City of birth
Measured: Up to 30 weeks
Current area of residence
City of residence
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Oct 2022
- Primary completion15 Jan 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Onsi Doss Hanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453890
- Sponsor's protocol ID
- POD 1
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population: A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT05453890
- Acronym / sponsor ID
- POD 1
- Conditions
- Gingival Pigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 12 Jul 2022 (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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A sample of adult egyptian population | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients whose age is 18 years old and above.
- Patient consulting in the diagnostic centre, Faculty of Dentistry, Cairo University.
- Provide informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of gingival pigmentation
Time frame: Up to 30 weeks
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
8 secondary outcomes
Age of the participant associated risk factors
Time frame: Up to 30 weeks
Gender of the participant
Time frame: Up to 30 weeks
Occupation of the participant
Time frame: Up to 30 weeks
Type of smoking
Time frame: Up to 30 weeks
Frequency of smoking
Time frame: Up to 30 weeks
Duration of smoking
Time frame: Up to 30 weeks
Place of birth
Time frame: Up to 30 weeks
Current area of residence
Time frame: Up to 30 weeks
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 3 Jul 2024.
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Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
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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 Gingival Pigmentation, run by Cairo 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 3 inclusion and 5 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 3 Jul 2024. 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?
Prevalence of gingival pigmentation (time frame: Up to 30 weeks). 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 3 Jul 2024.