IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
NCT ID: NCT05880654
Last Updated: 2023-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2023-01-01
2023-05-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Systemically healthy periodontitis
Non Surgical Periodontal therapy ( Scaling \& Root planning)
Scaling & root planning
Non Surgical periodontal therapy
Diabetic & Periodontitis
Non surgical periodontal therapy ( scaling \& root planning)
Scaling & root planning
Non Surgical periodontal therapy
Control
Healthy group with neither Diabetes nor Periodontitis
No interventions assigned to this group
Interventions
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Scaling & root planning
Non Surgical periodontal therapy
Eligibility Criteria
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Exclusion Criteria
2. Pregnancy
3. Lactation
4. Receiving professional periodontal treatment during the past 6 months
5. Current or former smokers
35 Years
50 Years
ALL
Yes
Sponsors
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Fayoum University
OTHER
Responsible Party
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Sandy Hassan
Associate professor oral medicine & periodontology departement
Principal Investigators
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sandy Hassan, ass.prof
Role: PRINCIPAL_INVESTIGATOR
associate professor
Locations
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Sandy hassan
Cairo, Virginia, Egypt
Sandy hassan shaaban
Cairo, , Egypt
Countries
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Other Identifiers
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#REC-FDBSU/06102022-02/HS
Identifier Type: -
Identifier Source: org_study_id
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