Condition, Chronic PeriodontitisNCT05995158
Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study
An observational study of Condition, Chronic Periodontitis, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Condition, Chronic Periodontitis
- What is being tested?
- Metagenomic testing of the subgingival plaque samples
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2022to 30 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adult patients clinically diagnosed to have chronic periodontitis
Who may be able to join
- 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.
Who cannot join
- Patients with any systemic diseases.
- Pregnant females.
- Patients who took any antibiotic in the past month.
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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.
- Conditions
- Condition, Chronic Periodontitis
- Being tested
- Metagenomic testing of the subgingival plaque samples
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic testing of the subgingival plaque samplesProcedure or surgery
sampling, extraction and sequencing of the oral microbiome in the samples
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Procedure: Metagenomic testing of the subgingival plaque samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral microbiome composition by NGS sequencing using next generation sequencer
Measured: 1 month
Secondary outcomes (2)
Probing depth (mm) by periodontal probe
Measured: 1 month
Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jan 2022
- Primary completion30 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition, Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jazia Alblowi, King Abdulaziz University
- Investigators
- Jazia A Alblowi, PhD, Principal investigator, King Abdulaziz University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995158
- Sponsor's protocol ID
- 127-10-18
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenomic Analysis of the Link Between Periodontitis and Smoking: Case-control Study
- ClinicalTrials.gov ID
- NCT05995158
- Acronym / sponsor ID
- 127-10-18
- Conditions
- Condition, Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers ≥ 10 cigarettes/day | – | Procedure: Metagenomic testing of the subgingival plaque samplesmetagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples) |
| Smokers < 10 cigarettes/day | – | Procedure: Metagenomic testing of the subgingival plaque samplesmetagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples) |
| non-smokers | – | Procedure: Metagenomic testing of the subgingival plaque samplesmetagenomic testing of the subgingival plaque samples 16S rRNA metagenomic testing (sampling, extraction and sequencing of the oral microbiome in the samples) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients clinically diagnosed to have chronic periodontitis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients with any systemic diseases.
- Pregnant females.
- Patients who took any antibiotic in the past month.
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic testing of the subgingival plaque samplessampling, extraction and sequencing of the oral microbiome in the samples | Procedure or surgery | Smokers < 10 cigarettes/day, Smokers ≥ 10 cigarettes/day, non-smokers |
Primary outcome
oral microbiome composition by NGS sequencing using next generation sequencer
Time frame: 1 month
2 secondary outcomes
Probing depth (mm) by periodontal probe
Time frame: 1 month
Bleeding on probing tested by a periodontal probe % of sites with bleeding on probing
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jazia A Alblowi, PhD principal investigator
King Abdulaziz University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Condition, Chronic Periodontitis, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
oral microbiome composition by NGS sequencing using next generation sequencer (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2023.