Skip to main content
OpenTrials
Completed

NCT Number: NCT05995158

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Abdulaziz University

Jeddah, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Metagenomic testing of the subgingival plaque samples

Procedure

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

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

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 16, 2023
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.