Aggressive PeriodontitisNCT05295576
Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients
An observational study of Aggressive Periodontitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- non surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2021to 30 Dec 2021
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Chronic periodontitis patients
Who may be able to join
- Medically free subjects .
- both genders .
- age range between 30 to 60 years old .
Who cannot join
- Subjects with periodontal surgeries in the last 6 months.
- Subjects with prior use of antibiotics in the last 6 months.
- Smokers.
- Pregnant and lactating females were excluded.
- Lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non Surgical Periodontal Therapy on Levels of Il-17 and Il-18 in Chronic Periodontitis Patients Versus Periodontally Healthy Individuals
The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy
Read the detailed description
Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus periodontally healthy controls.
Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Aggressive Periodontitis
- Being tested
- non surgical periodontal therapy
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical periodontal therapyProcedure or surgery
Scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| chronic periodontitis | scaling and root planing Receives: Procedure: non surgical periodontal therapy | |
| Periodontally healthy individuals | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure levels of Il-17 and Il-18 in chronic periodontitis patients
measure levels of Il-17 and Il-18 in GCF of chronic periodontitis patients
Measured: Change from Baseline Il-17 andIl-18 at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start27 Mar 2021
- Primary completion15 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elkot, Future University in Egypt
- Investigators
- Sarah M Elkot, Lecturer, Principal investigator, Lecturer of Oral Medicine and Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295576
- Sponsor's protocol ID
- FUE12
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non Surgical Periodontal Therapy on Levels of Il-17 and Il-18 in Chronic Periodontitis Patients Versus Periodontally Healthy Individuals
- ClinicalTrials.gov ID
- NCT05295576
- Acronym / sponsor ID
- FUE12
- Conditions
- Aggressive Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Mar 2022 (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.
The current study was performed to study levels of Il-17 and Il-18 in aggressive periodontitis patients before and after non surgical periodontal therapy
Detailed description
Background:host defense factors are involved in pathogenesis of chronic periodontitis so, the current study is assessing levels of Il-17 and Il-18 in chronic periodontitis patients versus periodontally healthy controls.
Subjects and methods: Fifty subjects were included; twenty five of them are diagnosed with chronic periodontitis patients and twenty five are periodontally healthy subjects. Probing depth (PD), clinical attachment level (CAL), plaque index (PI) and gingival index (GI) were recorded for all the enrolled subjects. GCF levels of Il-17 and IL-18 were analyzed by enzyme-linked immunosorbent assay (ELISA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic periodontitis | – | Procedure: non surgical periodontal therapyscaling and root planing |
| Periodontally healthy individuals | – | –no treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chronic periodontitis patients
Key inclusion criteria (3 listed)
- Medically free subjects .
- both genders .
- age range between 30 to 60 years old .
Key exclusion criteria (5 listed)
- Subjects with periodontal surgeries in the last 6 months.
- Subjects with prior use of antibiotics in the last 6 months.
- Smokers.
- Pregnant and lactating females were excluded.
- Lactating females.
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 |
|---|---|---|
| non surgical periodontal therapyScaling and root planing | Procedure or surgery | chronic periodontitis |
Primary outcome
measure levels of Il-17 and Il-18 in chronic periodontitis patients
Time frame: Change from Baseline Il-17 andIl-18 at 3 months
measure levels of Il-17 and Il-18 in GCF of chronic periodontitis patients
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 25 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sarah M Elkot, Lecturer principal investigator
Lecturer of Oral Medicine and Periodontology
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 Aggressive Periodontitis, run by Future University in Egypt 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 3 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 25 Mar 2022. 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?
measure levels of Il-17 and Il-18 in chronic periodontitis patients (time frame: Change from Baseline Il-17 andIl-18 at 3 months). 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 25 Mar 2022.