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.

Study Overview

• Status: Completed
• Conditions: Condition, Chronic Periodontitis
• Intervention / Treatment: Procedure: Metagenomic testing of the subgingival plaque samples

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21589
    • King Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patients clinically diagnosed to have chronic periodontitis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; sampling, extraction and sequencing of the oral microbiome in the 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; sampling, extraction and sequencing of the oral microbiome in the 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; sampling, extraction and sequencing of the oral microbiome in the samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
oral microbiome composition by NGS sequencing using next generation sequencer	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Probing depth (mm) by periodontal probe	1 month
Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing	1 month

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Jazia A Alblowi, PhD, King Abdulaziz University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Disease; Chronic Periodontitis
• Other Study ID Numbers: 127-10-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No