IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis

NCT ID: NCT05880654

Last Updated: 2023-05-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-05-15

Brief Summary

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The sudy was aiming to assess and compare GCF levels of IL-39 \& IL-35 in gingival crevicular fluid and to correlate the relationship between different patient groups before and after non-surgical therapy.

Detailed Description

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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.

Conditions

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Generalized Periodontal Disease, AVDC Stage 3

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Chronic periodontitis group chronic periodontitis with diabetes control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systemically healthy periodontitis

Non Surgical Periodontal therapy ( Scaling \& Root planning)

Group Type ACTIVE_COMPARATOR

Scaling & root planning

Intervention Type PROCEDURE

Non Surgical periodontal therapy

Diabetic & Periodontitis

Non surgical periodontal therapy ( scaling \& root planning)

Group Type ACTIVE_COMPARATOR

Scaling & root planning

Intervention Type PROCEDURE

Non Surgical periodontal therapy

Control

Healthy group with neither Diabetes nor Periodontitis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Scaling & root planning

Non Surgical periodontal therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

1. Patients treated with any type of medications and/ or antibiotics during the past 3 months,
2. Pregnancy
3. Lactation
4. Receiving professional periodontal treatment during the past 6 months
5. Current or former smokers
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Sandy Hassan

Associate professor oral medicine & periodontology departement

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Sandy hassan shaaban

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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#REC-FDBSU/06102022-02/HS

Identifier Type: -

Identifier Source: org_study_id

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