Smoking ReductionNCT04861493
Cathelicidin LL-37 Levels in the GCF and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis
An observational study of Smoking Reduction, run by Cairo University at 1 site in Egypt.
Trial summary
Periodontitis is considered an inflammatory disease that results in the disruption of oral hemeostasis and is associated with the presence of dental plaque influenced by genetic and environmental factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Reduction
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2021to 15 Apr 2021
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Group 1: Smokers with stage III,IV periodontitis Group 2: Non-smokers with stage III,IV periodontitis Group 3: Healthy patients
Who may be able to join
- Presence of a minimum of 15 natural teeth.
- At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD > 5 mm in one or more sites.
- Bleeding on probing (BOP) ≥ 30%.
- Tooth loss due to periodontitis ≤ 4 teeth.
- For smoker's patients; study will include patients who regularly smoked at least 10 cigarettes/day for a minimum of 5 years.
- For non-smokers patients; study will include patients who had never smoked.
Who cannot join
- Individuals with a history of systemic diseases or immunological disorders.
- Individuals using hormone replacement therapy.
- Pregnant and lactating women.
- Individuals that received periodontal treatment within the last 6 months.
- Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry cairo university
Al Manyal, Cairo Governorate, 11562
About this study
Official title: Cathelicidin LL-37 Levels in the Gingival Crevicular Fluid and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis :An Observational Study
Periodontitis is considered an inflammatory disease that results in the disruption of oral hemeostasis and is associated with the presence of dental plaque influenced by genetic and environmental factors. It is well-establised that smokers have an increased severity of periodontal disease,a higher prevalance of tooth loss and total edentulism.
Read the detailed description
Antimicrobial peptides (AMPs) are soluble molecules participating in the innate immunity of mucosal surfaces against pathogens. Dysregulated expression of AMPs has been considered a possible causal mechanistic link in the microbial dysbiosis associated with periodontal disease and some risk factors, including tobacco smoking, diabetes mellitus, and obesity.Antimicrobial peptides as a part of innate immunity are important molecules that provide a balance between disease and health. Moreover, they are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the gingival epithelium and in the transition to acquired immunity. Cathelicidins, in particular - which play an important role in regulating the immunological response of oral tissues, are a group of peptides released from neutrophil granules and they are present only in humans in the form of LL-37.
- Conditions
- Smoking Reduction
- Medical subject headings
- Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers with stage III,IV periodontitis | patients with stage III,IV periodontitis having CAL>5 mm and PD>5 mm in one or more sites and bleeding on probing >30% and smoking at least 10 cigarettes /day for a minmum of 5 years. | |
| Non-smokers with stage III,IV periodontitis | patients with stage III,IV periodontitis having CAL>5 mm and PD>5 mm in one or more sites and bleeding on probing >30% and they are never smoked before. | |
| Healthy patients | patients free from periodontitis or any systemic disease and never smoked before. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LL-37 levels in the GCF and saliva
GCF,Saiva sampling to assess LL-37 levels by ELISA kit.
Measured: Through study completion,an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start23 Feb 2021
- Primary completion23 Feb 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking ReductionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Magdy Abu El Eneen, Cairo University
- Investigators
- Ghallab, Study director, main supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861493
- Sponsor's protocol ID
- 9221
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathelicidin LL-37 Levels in the Gingival Crevicular Fluid and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis :An Observational Study
- ClinicalTrials.gov ID
- NCT04861493
- Acronym / sponsor ID
- 9221
- Conditions
- Smoking Reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 27 Apr 2021 (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 considered an inflammatory disease that results in the disruption of oral hemeostasis and is associated with the presence of dental plaque influenced by genetic and environmental factors. It is well-establised that smokers have an increased severity of periodontal disease,a higher prevalance of tooth loss and total edentulism.
Detailed description
Antimicrobial peptides (AMPs) are soluble molecules participating in the innate immunity of mucosal surfaces against pathogens. Dysregulated expression of AMPs has been considered a possible causal mechanistic link in the microbial dysbiosis associated with periodontal disease and some risk factors, including tobacco smoking, diabetes mellitus, and obesity.Antimicrobial peptides as a part of innate immunity are important molecules that provide a balance between disease and health. Moreover, they are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the gingival epithelium and in the transition to acquired immunity. Cathelicidins, in particular - which play an important role in regulating the immunological response of oral tissues, are a group of peptides released from neutrophil granules and they are present only in humans in the form of LL-37.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers with stage III,IV periodontitis | – | –patients with stage III,IV periodontitis having CAL>5 mm and PD>5 mm in one or more sites and bleeding on probing >30% and smoking at least 10 cigarettes /day for a minmum of 5 years. |
| Non-smokers with stage III,IV periodontitis | – | –patients with stage III,IV periodontitis having CAL>5 mm and PD>5 mm in one or more sites and bleeding on probing >30% and they are never smoked before. |
| Healthy patients | – | –patients free from periodontitis or any systemic disease and never smoked before. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Group 1: Smokers with stage III,IV periodontitis Group 2: Non-smokers with stage III,IV periodontitis Group 3: Healthy patients
Key inclusion criteria (6 listed)
- Presence of a minimum of 15 natural teeth.
- At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD > 5 mm in one or more sites.
- Bleeding on probing (BOP) ≥ 30%.
- Tooth loss due to periodontitis ≤ 4 teeth.
- For smoker's patients; study will include patients who regularly smoked at least 10 cigarettes/day for a minimum of 5 years.
Key exclusion criteria (5 listed)
- Individuals with a history of systemic diseases or immunological disorders.
- Individuals using hormone replacement therapy.
- Pregnant and lactating women.
- Individuals that received periodontal treatment within the last 6 months.
- Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LL-37 levels in the GCF and saliva
Time frame: Through study completion,an average of 1 year
GCF,Saiva sampling to assess LL-37 levels by ELISA kit.
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 27 Apr 2021.
- Individual participant dataSharing planned: Yes
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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.
Ghallab study director
main supervisor
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 Smoking Reduction, run by Cairo University at 1 site in Egypt.
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 6 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 27 Apr 2021. 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 Egypt. 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?
LL-37 levels in the GCF and saliva (time frame: Through study completion,an average of 1 year). 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 27 Apr 2021.