Periodontal HealthNCT04509843
Impact of Socioeconomic Status and Oral Hygiene Practice on Periodontal Health of Egyptian Adults
An observational study of Periodontal Health, run by Alsayed Mohamed Alsayed Alsadany at 1 site in Egypt.
Trial summary
evaluation the relationship between the socioeconomic status and periodontal health of Egyptian adults. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Health
- What is being tested?
- socioeconomic status
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 456 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Apr 2021
- How long will I take part?
- 1 Month
- 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 70 years
- All sexes
- Adult, Older adult
Study population: patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Who may be able to join
- -Patients whose age is 18-70 years old recruiting from the outpatient clinic and the payed clinic
- Provide informed consent.
Who cannot join
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- pregnant patients.
- patients undergoing orthodontic treatment.
- patients who had undergone periodontal treatment over the past six months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 002
dentistry cu Cairo university, (002)(02) 23642705 ext. 522, ethics@dentistry.cu.edu.eg
About this study
Official title: Impact of Socioeconomic Status and Oral Hygiene Practice on Periodontal Health of Egyptian Adults: A Hospital Based Cross-sectional Study
evaluation the relationship between the socioeconomic status and periodontal health of Egyptian adults.
Read the detailed description
It is a cross-sectional study for evaluation and assessment of periodontal health, socioeconomic status and oral hygiene measurements among Egyptian adults recruiting from the outpatient clinic and the payed treatment clinics at faculty of Dentistry, Cairo University.
The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center.
- Conditions
- Periodontal Health
- Being tested
- socioeconomic status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socioeconomic statusBehavioural
it is a cross-sectional study for assessment the impact of socioeconomic status on periodontal health through using a definite scale mentioned in the protocol related to the middle east people.
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal health
Recently, definition of periodontal health has been developed dramatically from just the absence of a disease to a state around a stable periodontium (Lang and Bartold, 2018) that functions in comfort in an individual with psychological and social well-being about their mouth (Mariotti and Hefti, 2015). Based on this, biological, environmental, systemic, social, economic and psychological factors can affect periodontal health in different ways.
Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The CPITN criteria used in this study will be as follows: score 0 = healthy periodontium with no sign of periodontal disease, score 1= gingival bleeding on probing, 2=calculus deposits, 3=pockets 4-5mm (shallow pockets), 4=pockets 6mm or deeper (deep pockets) and X =excluded sextants.
Measured: "through study completion, an average of 1 year"
periodontal disease
Periodontal diseases have been categorized in a new framework: stage I to VI of periodontitis based on severity, complexity of management with additional described extent as localized or generalized. Grade A to C of periodontitis related to the progression rate of the disease as slow, moderate and rapid with grade modifiers. The seriousness and the complexity of the disease are greater as the grade increases within each stage.(Tonetti, Greenwell and Kornman, 2018).
Information on loss of attachment (CAL) will be collected from the same index teeth using CPI modified system. The two molars in each posterior sextant are paired for recording and if one is missing there is no replacement. If no index tooth is present in a sextant qualifying for examination, all teeth present in that sextant are examined and the highest score is recorded as the score for the sextant WHO.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Impact of sociodemographic factors on periodontal health
Patient-centered approaches turned to be more popular, which increased the attention to the effects of different human health situations on periodontal health through the concept that the way in which an individual' lives may produce behavioural patterns that are either beneficial or determinable to health including socioeconomic status.
Social class will be classified according to following socioeconomic status scale for health research in Egypt into low, moderate and high socioeconomic subgroups described by El-Gilany et al. (El-Gilany, El-Wehady and El-Wasify, 2012) This scale includes 7 domains with a total score of 84. Socioeconomic level: to be classified into very low, low, middle and high levels depending on the quartiles of the score calculated.
Measured: through study completion, an average of 1 year
impact of periodontal practice on periodontal health
(Lertpimonchai et al., 2017) concluded that fair to poor oral hygiene measures especially irregular tooth brushing increases the risk of periodontal disease by two to five folds in conjunction with low frequency tooth brushing which was conducted in a systematic-review with severe forms of periodontal diseases.
periodontal practice will be addressed via several questions that evaluate the self-care practices of tooth brushing, flossing, mouth rinsing in recent one year, scaling in recent five years, and how to alleviate gingival bleeding if there is.The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal HealthStudies of the same condition, open and under way.
- 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
- 456 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Alsayed Mohamed Alsayed Alsadany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alsayed Mohamed Alsayed Alsadany, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509843
- Sponsor's protocol ID
- 3-4-20
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will share final statistical results.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Socioeconomic Status and Oral Hygiene Practice on Periodontal Health of Egyptian Adults: A Hospital Based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04509843
- Acronym / sponsor ID
- 3-4-20
- Conditions
- Periodontal Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Alsayed Mohamed Alsayed AlsadanyUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 12 Aug 2020 (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.
evaluation the relationship between the socioeconomic status and periodontal health of Egyptian adults.
Detailed description
It is a cross-sectional study for evaluation and assessment of periodontal health, socioeconomic status and oral hygiene measurements among Egyptian adults recruiting from the outpatient clinic and the payed treatment clinics at faculty of Dentistry, Cairo University.
The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Key inclusion criteria (2 listed)
- -Patients whose age is 18-70 years old recruiting from the outpatient clinic and the payed clinic
- Provide informed consent.
Key exclusion criteria (5 listed)
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- pregnant patients.
- patients undergoing orthodontic treatment.
- patients who had undergone periodontal treatment over the past six months.
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 |
|---|---|---|
| socioeconomic statusit is a cross-sectional study for assessment the impact of socioeconomic status on periodontal health through using a definite scale mentioned in the protocol related to the middle east people. | Behavioural | – |
Primary outcome
Periodontal health
Time frame: "through study completion, an average of 1 year"
Recently, definition of periodontal health has been developed dramatically from just the absence of a disease to a state around a stable periodontium (Lang and Bartold, 2018) that functions in comfort in an individual with psychological and social well-being about their mouth (Mariotti and Hefti, 2015). Based on this, biological, environmental, systemic, social, economic and psychological factors can affect periodontal health in different ways. Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The CPITN criteria used in this study will be as follows: score 0 = healthy periodontium with no sign of periodontal disease, score 1= gingival bleeding on probing, 2=calculus deposits, 3=pockets 4-5mm (shallow pockets), 4=pockets 6mm or deeper (deep pockets) and X =excluded sextants.
periodontal disease
Time frame: through study completion, an average of 1 year
Periodontal diseases have been categorized in a new framework: stage I to VI of periodontitis based on severity, complexity of management with additional described extent as localized or generalized. Grade A to C of periodontitis related to the progression rate of the disease as slow, moderate and rapid with grade modifiers. The seriousness and the complexity of the disease are greater as the grade increases within each stage.(Tonetti, Greenwell and Kornman, 2018). Information on loss of attachment (CAL) will be collected from the same index teeth using CPI modified system. The two molars in each posterior sextant are paired for recording and if one is missing there is no replacement. If no index tooth is present in a sextant qualifying for examination, all teeth present in that sextant are examined and the highest score is recorded as the score for the sextant WHO.
2 secondary outcomes
Impact of sociodemographic factors on periodontal health
Time frame: through study completion, an average of 1 year
impact of periodontal practice on periodontal health
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: Undecided. i will share final statistical results.
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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.
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 Periodontal Health, run by Alsayed Mohamed Alsayed Alsadany 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 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: status not confirmed, as of the sponsor's last update on 12 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alsayed mo alsadany, master (+201094741442, alsayed.alsadany@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal health (time frame: "through study completion, an average of 1 year"). 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 Aug 2020.