Aggressive PeriodontitisNCT05297084
Non Surgical Periodontal Treatment Effect on Il-17 and Il-18 in Aggressive Periodontitis
An observational study of Aggressive Periodontitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
clinical parameters and IL-17 and Il-18 GCF levels were measured in 25 aggressive periodontitis patients compared to 25 periodontally healthy individuals. It was observed that that Clinical parameters and Il-17 and Il-18 levels are higher before treatment but decreased after treatment which suggests role of these… Read more about this study
- Who is it for?
- Ages 18 to 30 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Both genders Age between 18 and 30 years old
Who may be able to join
- -Medically free subjects.
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 females.
- Lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non Surgical Periodontal Treatment on Clinical Parameters and Gingival Crevicular Fluid Il-17 and Il-18 Levels in Aggressive Periodontitis Patients
clinical parameters and IL-17 and Il-18 GCF levels were measured in 25 aggressive periodontitis patients compared to 25 periodontally healthy individuals.
It was observed that that Clinical parameters and Il-17 and Il-18 levels are higher before treatment but decreased after treatment which suggests role of these interleukins in pathogenesis of aggressive periodontitis .
Read the detailed description
Aggressive periodontitis is a type of rapidly progressing periodontal diseases .The three classic primary characteristics of this disease are ; occurring in young healthy patients with rapid attachment loss and familial aggregation .Bacteria-host interactions, insufficiencies in host defenses and possibly a genetic predisposition represent the etiologic factors . Beside the young age of onset, important factors as involvement of host factors and non-plaque-related etiologic factors have also been proposed .
Aim of the study:
Objectives were to compare and correlate the clinical parameters and biochemical parameters (Il-17 and Il-18 levels in GCF) of aggressive periodontitis patients (At baseline and after three months of nonsurgical treatment) versus periodontally healthy subjects at baseline.
Subjects and methods:
Populations included in the study:
A total of fifty individuals were enrolled and categorized as; group A that included twenty five aggressive periodontitis patients and group B which included twenty five periodontally healthy controls.
Clinical parameters:
Plaque index (PI) ,gingival index (GI), Probing pocket depth (PPD) and clinical attachment level (CAL) were measured at baseline for both groups and after three months of non surgical periodontal treatment completion for group A.
GCF sampling:
In group A ,the site with deepest probing depth was selected for GCF sampling while for group B , any site was sampled using PerioPaper strips .
Phase I periodontal treatment After baseline GCF sample collection and clinical measurement recordings, group A patients received phase I periodontal treatment.
Analysis of Il-17 and Il-18 levels in GCF:
GCF samples were examined by enzyme-linked immunosorbent assay (ELISA).Procedures were performed according to the directions in the kits.
- Conditions
- Aggressive Periodontitis
- Being tested
- non surgical periodontal therapy
- Keywords
- gingival crevicular fluid
- 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 |
|---|---|---|
| Aggressive periodontitis | 25 young medically free patients with deep periodontal pockets >5mm Receives: Procedure: non surgical periodontal therapy | |
| Periodontally healthy individuals | 25 young medically free individuals with no periodontal inflammation signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periopaper strips Il-17 and Il-18 GCF measurements
measurement of Il-17 and Il-18 in GCF from aggressive periodontitis patients using periopaper strips
Measured: Change from Baseline Il-17 and Il-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
- Cohort
- 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
- NCT05297084
- Sponsor's protocol ID
- FUE11
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non Surgical Periodontal Treatment on Clinical Parameters and Gingival Crevicular Fluid Il-17 and Il-18 Levels in Aggressive Periodontitis Patients
- ClinicalTrials.gov ID
- NCT05297084
- Acronym / sponsor ID
- FUE11
- Conditions
- Aggressive Periodontitis
- Keywords
- gingival crevicular fluid
- 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.
clinical parameters and IL-17 and Il-18 GCF levels were measured in 25 aggressive periodontitis patients compared to 25 periodontally healthy individuals.
It was observed that that Clinical parameters and Il-17 and Il-18 levels are higher before treatment but decreased after treatment which suggests role of these interleukins in pathogenesis of aggressive periodontitis .
Detailed description
Aggressive periodontitis is a type of rapidly progressing periodontal diseases .The three classic primary characteristics of this disease are ; occurring in young healthy patients with rapid attachment loss and familial aggregation .Bacteria-host interactions, insufficiencies in host defenses and possibly a genetic predisposition represent the etiologic factors . Beside the young age of onset, important factors as involvement of host factors and non-plaque-related etiologic factors have also been proposed .
Aim of the study:
Objectives were to compare and correlate the clinical parameters and biochemical parameters (Il-17 and Il-18 levels in GCF) of aggressive periodontitis patients (At baseline and after three months of nonsurgical treatment) versus periodontally healthy subjects at baseline.
Subjects and methods:
Populations included in the study:
A total of fifty individuals were enrolled and categorized as; group A that included twenty five aggressive periodontitis patients and group B which included twenty five periodontally healthy controls.
Clinical parameters:
Plaque index (PI) ,gingival index (GI), Probing pocket depth (PPD) and clinical attachment level (CAL) were measured at baseline for both groups and after three months of non surgical periodontal treatment completion for group A.
GCF sampling:
In group A ,the site with deepest probing depth was selected for GCF sampling while for group B , any site was sampled using PerioPaper strips .
Phase I periodontal treatment After baseline GCF sample collection and clinical measurement recordings, group A patients received phase I periodontal treatment.
Analysis of Il-17 and Il-18 levels in GCF:
GCF samples were examined by enzyme-linked immunosorbent assay (ELISA).Procedures were performed according to the directions in the kits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive periodontitis | – | Procedure: non surgical periodontal therapy25 young medically free patients with deep periodontal pockets >5mm |
| Periodontally healthy individuals | – | –25 young medically free individuals with no periodontal inflammation signs |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Both genders Age between 18 and 30 years old
Key inclusion criteria (1 listed)
- -Medically free subjects.
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 females.
- 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 | Aggressive periodontitis |
Primary outcome
Periopaper strips Il-17 and Il-18 GCF measurements
Time frame: Change from Baseline Il-17 and Il-18 at 3 months
measurement of Il-17 and Il-18 in GCF from aggressive periodontitis patients using periopaper strips
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 7 Apr 2022.
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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 1 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 7 Apr 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?
Periopaper strips Il-17 and Il-18 GCF measurements (time frame: Change from Baseline Il-17 and Il-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 7 Apr 2022.