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PeriodontitisNCT03901911

Prevalence of Periodontitis on a Sample of Adult Egyptian Population

An observational study of Periodontitis, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

  1. 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.

  1. First posted3 Apr 2019
  2. Study start1 Apr 2019 (estimated)
  3. Primary completion1 Oct 2019 (estimated)
  4. Study completion1 Apr 2020 (estimated)

Resources

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)
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

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.

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