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

Sponsor
King Abdulaziz University (Other)
Overall Status
Completed
CT.gov ID
NCT05995158
Collaborator
(none)
60
1
12.9
4.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Metagenomic testing of the subgingival plaque samples

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Nov 30, 2022
Actual Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Probing depth (mm) by periodontal probe [1 month]

  2. Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Abdulaziz University Jeddah Saudi Arabia 21589

Sponsors and Collaborators

  • King Abdulaziz University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jazia Alblowi, Associate Professor, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT05995158
Other Study ID Numbers:
  • 127-10-18
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2023