PeriodontitisNCT03901911
Prevalence of Periodontitis on a Sample of Adult Egyptian Population
An observational study of Periodontitis, run by Cairo University.
Trial summary
Observational cross-sectional study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 1,708 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2020
- 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: Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.
Who may be able to join
- All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.
Who cannot join
- patients undergone periodontal therapy in the last 6 months.
- patients with psychomotor dysfunction.
- Patients less than 18 years old.
- Edentulous patients
About this study
Official title: Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional Study I
Observational cross-sectional study
Read the detailed description
Adult patients will be included by consecutive manner from the diagnostic center at the Faculty of Dentistry.
All the patient information and medical history will be obtained from the patient and recorded byte principal investigator of this study.
Dental examinationof permanent fully erupted teeth will be performed by the principal investigator of this study, excluding third molars, retained roots, and implants.
Periodontal examinations will be performed using full-mouth periodontal examination (FMEP) methodology.
Periodontitis is defined here as 1-2 mm clinical attachment loss (CAL)in interproximal area in two non-adjacent teeth and Staging involves four categories (stages 1 through 4) and is determined after considering several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis.
Grading includes three levels (grade A - low risk, grade B - moderate risk, grade C - high risk for progression) and encompasses, in addition to aspects related to periodontitis progression, general health status, and other exposures such as smoking or level of metabolic control in diabetes.
Aim of the Study will be explained to the patient, and informed consent will be given to him to sign and will be maintained with the rest of the data .
The evaluated parameters will be: clinical attachment loss (CAL), probing depth (PD), bleeding on probing (BOP), gingival recession (GR), plaque index (PI), furcation involvement ,tooth mobility and radiographic examination.
(CAL)will be Measured from the CEJ to the bottom of the gingival sulcus using Williams marking probe.
PD will be measured at six sites per tooth (mesiobuccal,mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual), PD will be measured as the distance from the cemento enamel junction (CEJ) to the bottom of the pocket using Williams marking probe.
GR will be measured as the distance from the CEJ to the free gingival margin, and this assessment will be assigned negative sign if the gingival margin is located coronally to the CEJ using Williams marking probe.
BOP gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
PI the measurement of the state of oral hygiene by Silness-Löe Plaque index is based on recording both soft debris and mineralized deposits on the teeth using Williams marking probe. Missing teeth are not substituted.
0 No plaque
1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2 Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
3 Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Furcation involvement will be measured according to Glickman,1953 using Naber's Furcation Probe.
Radiographic examination will be performed by periapical radiograph for the most affected area to measure the linear measurement of bone loss \& calculate the percentage of bone loss.
According to the Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions :
In grade A, there is slow rate of progression where the percentage of bone loss divided by age is less than 0.25.
In grade B there is a moderate rate of progression where the percentage of bone loss divided by age is from 0.25 to 1.0.
In grade C there is a rapid rate of progression where the percentage of bone loss divided by age is greater than 1.0.
- Conditions
- Periodontitis
- Medical subject headings
- Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of periodontitis in percentage
Prevalence of periodontitis on a Sample of Adult Egyptian Population through determining clinical attachment loss.
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Hamed Nada, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901911
- Sponsor's protocol ID
- CEBD-CU-2018-12-13
- Status last verified
- Apr 2019
- First submitted
- 20 Jan 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.
PubMed 29926490
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional Study I
- ClinicalTrials.gov ID
- NCT03901911
- Acronym / sponsor ID
- CEBD-CU-2018-12-13
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,708 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 3 Apr 2019 (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.
Observational cross-sectional study
Detailed description
Adult patients will be included by consecutive manner from the diagnostic center at the Faculty of Dentistry.
All the patient information and medical history will be obtained from the patient and recorded byte principal investigator of this study.
Dental examinationof permanent fully erupted teeth will be performed by the principal investigator of this study, excluding third molars, retained roots, and implants.
Periodontal examinations will be performed using full-mouth periodontal examination (FMEP) methodology.
Periodontitis is defined here as 1-2 mm clinical attachment loss (CAL)in interproximal area in two non-adjacent teeth and Staging involves four categories (stages 1 through 4) and is determined after considering several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects and furcation involvement, tooth mobility, and tooth loss due to periodontitis.
Grading includes three levels (grade A - low risk, grade B - moderate risk, grade C - high risk for progression) and encompasses, in addition to aspects related to periodontitis progression, general health status, and other exposures such as smoking or level of metabolic control in diabetes.
Aim of the Study will be explained to the patient, and informed consent will be given to him to sign and will be maintained with the rest of the data .
The evaluated parameters will be: clinical attachment loss (CAL), probing depth (PD), bleeding on probing (BOP), gingival recession (GR), plaque index (PI), furcation involvement ,tooth mobility and radiographic examination.
(CAL)will be Measured from the CEJ to the bottom of the gingival sulcus using Williams marking probe.
PD will be measured at six sites per tooth (mesiobuccal,mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual), PD will be measured as the distance from the cemento enamel junction (CEJ) to the bottom of the pocket using Williams marking probe.
GR will be measured as the distance from the CEJ to the free gingival margin, and this assessment will be assigned negative sign if the gingival margin is located coronally to the CEJ using Williams marking probe.
BOP gentle probing of the orifice of the gingival crevice. The periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.
PI the measurement of the state of oral hygiene by Silness-Löe Plaque index is based on recording both soft debris and mineralized deposits on the teeth using Williams marking probe. Missing teeth are not substituted.
0 No plaque
1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2 Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
3 Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Furcation involvement will be measured according to Glickman,1953 using Naber's Furcation Probe.
Radiographic examination will be performed by periapical radiograph for the most affected area to measure the linear measurement of bone loss \& calculate the percentage of bone loss.
According to the Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions :
In grade A, there is slow rate of progression where the percentage of bone loss divided by age is less than 0.25.
In grade B there is a moderate rate of progression where the percentage of bone loss divided by age is from 0.25 to 1.0.
In grade C there is a rapid rate of progression where the percentage of bone loss divided by age is greater than 1.0.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.
Key inclusion criteria (1 listed)
- All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.
Key exclusion criteria (4 listed)
- patients undergone periodontal therapy in the last 6 months.
- patients with psychomotor dysfunction.
- Patients less than 18 years old.
- Edentulous patients
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 periodontitis in percentage
Time frame: 6 MONTHS
Prevalence of periodontitis on a Sample of Adult Egyptian Population through determining clinical attachment loss.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 29926490Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Cairo University.
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 1 inclusion and 4 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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 periodontitis in percentage (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901911, which also lists 1 linked publication.
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 Apr 2019.