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CompletedNCT05995158Updated Aug 16, 2023

Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study

An observational study in Condition, Chronic Periodontitis, sponsored by King Abdulaziz University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-16.

Sponsored by King Abdulaziz University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

Periodontitis is a widely prevalent disease worldwide that has serious public health consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. Consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly.

Dysbiotic changes in the oral microbiome arise after some microbial species are enriched by primary products resulting from tissue breakdown due to gingivitis. It then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm.

However, the dysbiotic changes may be more likely to occur in some patients rather than others due to certain risk factors including smoking and immuneinflammatory responses. Thus, the severity of periodontal disease in these patients would be higher. Tobacco smoking is no longer considered to be a habit, but a dependence to nicotine and a chronic relapsing medical disorder. Among its detrimental effects on general health, tobacco smoking increases the risk of periodontitis by 2 to 5 folds. This takes place by increasing the dysbiotic changes in the oral microbiome and so, increasing the severity and extent of the periodontal disease at a younger age. Therefore, smoking has been considered as a modifying factor of periodontitis that should be considered upon periodontitis case grading definition.

Therefore, this research aims to identify the difference in dysbiosis between the three categories of periodontitis, trying to understand the cause of the resistance of each category to treatment compared to the milder category.

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Conditions studied

  • Condition, Chronic Periodontitis
03

In context

Periodontitis

1,634 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 60 is below the median of 89 across 427 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

King Abdulaziz University is the lead sponsor of 96 studies on the registry; 18 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients clinically diagnosed to have chronic periodontitis

Inclusion criteria

  • Patients 18 years or older.
  • Patients with periodontitis.
  • Probing pocket depth ≥ 4 mm.
  • Teeth with CAL≥ 3 mm at ≥2 non-adjacent teeth.
  • Clinical indication and/or patient request for treatment of the periodontal condition.

Exclusion criteria

Exclusion Criteria:

  • Patients with any systemic diseases.
  • Pregnant females.
  • Patients who took any antibiotic in the past month.
  • Handicapped and mentally retarded patients.
  • Patients undergoing radiotherapy.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Smokers ≥ 10 cigarettes/day

    metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)

    Procedure: Metagenomic testing of the subgingival plaque samples

  • Smokers < 10 cigarettes/day

    metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)

    Procedure: Metagenomic testing of the subgingival plaque samples

  • non-smokers

    metagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples)

    Procedure: Metagenomic testing of the subgingival plaque samples

Interventions

  • ProcedureMetagenomic testing of the subgingival plaque samples

    sampling, extraction and sequencing of the oral microbiome in the samples

06

What researchers measure

Primary outcomes

  1. oral microbiome composition by NGS sequencing using next generation sequencer

    Time frame: 1 month

Secondary outcomes

  1. Probing depth (mm) by periodontal probe

    Time frame: 1 month

  2. Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing

    Time frame: 1 month

07

Study locations

1 site
  • King Abdulaziz University
    Jeddah, 21589, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05995158
Lead sponsor
King Abdulaziz University
Responsible party
Jazia Alblowi (Associate Professor, King Abdulaziz University) — Principal investigator
First posted
Aug 16, 2023
Start date
Jan 1, 2022
Primary completion
Nov 30, 2022
Completion
Jan 30, 2023
Last update
Aug 16, 2023

Study contacts

Jazia A Alblowi, PhD
principal investigator · King Abdulaziz University Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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