- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880654
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
Study Overview
Status
Intervention / Treatment
Detailed Description
Methodology:
Group I (Periodontitis Group): 19 patients suffering from generalized periodontitis with T2DM age range, 35-50 years.
Group II (Periodontitis Group): 19 patients suffering from generalized periodontitis & systemically healthy, age range: 35-50 years.
Group III (Control group): 19 Periodontally and systemically healthy volunteers who served as control subjects age range: 30-45 years.
Periodontitis participants will be collected from the outpatient clinic of oral medicine and periodontology departments in Fayoum, Beni-Swief and Ahram-Candian universities. The periodontitis included subjects will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Tonetti, MS, Greenwell, H, Kornman, KS. Staging and grading of periodontitis: framework and proposal of a new classification and case definition. J Periodontol.; 89( Suppl 1): S159- S172, 2018.)
Diabetic patients will be enrolled in this study according to the criteria of American Diabetes Association. (American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care 38: S8-S16, 2015.)
The control group will be selected from healthy subjects who attended the restorative dental clinic and has apparently clinically healthy gingiva.
Micropipettes will be used for collection of GCF samples for control group and periodontitis patients before & after periodontal treatment.
A complete mouth non-surgical periodontal therapy will be carried out for both periodontitis groups
The levels of IL-35 in the GCF samples were assessed using an ELISA kit following the guidelines by the manufacturer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Sandy hassan shaaban
-
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Virginia
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Cairo, Virginia, Egypt, 22039
- Sandy hassan
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Stage III Grade C Generalized periodontitis with diabetes Stage III grade B Generalized periodontitis in systemic healthy subjects
Exclusion Criteria:
- Patients treated with any type of medications and/ or antibiotics during the past 3 months,
- Pregnancy
- Lactation
- Receiving professional periodontal treatment during the past 6 months
- Current or former smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Systemically healthy periodontitis
Non Surgical Periodontal therapy ( Scaling & Root planning)
|
Non Surgical periodontal therapy
|
Active Comparator: Diabetic & Periodontitis
Non surgical periodontal therapy ( scaling & root planning)
|
Non Surgical periodontal therapy
|
No Intervention: Control
Healthy group with neither Diabetes nor Periodontitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GCF levels of IL-39 & IL35
Time Frame: 3 months
|
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis
|
3 months
|
Effect of SRP on GCF levels of IL-39 & IL35
Time Frame: 3 MONTHS
|
Gingival crevicular fluid levels of IL-39 & IL-35 in healthy & diabetic patients with periodontitis after Scaling & root planning
|
3 MONTHS
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: sandy Hassan, ass.prof, Associate Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #REC-FDBSU/06102022-02/HS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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