NCT05880654

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 19, 2023

Last Update Submit

May 19, 2023

Conditions

Generalized Periodontal Disease, AVDC Stage 3

Keywords

Periodontitis & Diabetes mellitus

Outcome Measures

Primary Outcomes (2)

  • GCF levels of IL-39 & IL35

    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

    Gingival crevicular fluid levels of IL-39 \& IL-35 in healthy \& diabetic patients with periodontitis after Scaling \& root planning

    3 MONTHS

Study Arms (3)

Systemically healthy periodontitis

ACTIVE COMPARATOR

Non Surgical Periodontal therapy ( Scaling \& Root planning)

Procedure: Scaling & root planning

Diabetic & Periodontitis

ACTIVE COMPARATOR

Non surgical periodontal therapy ( scaling \& root planning)

Procedure: Scaling & root planning

Control

NO INTERVENTION

Healthy group with neither Diabetes nor Periodontitis

Interventions

Scaling & root planningPROCEDURE

Non Surgical periodontal therapy

Diabetic & PeriodontitisSystemically healthy periodontitis

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sandy hassan

Cairo, Virginia, 22039, Egypt

Location

Sandy hassan shaaban

Cairo, Egypt

Location

MeSH Terms

Conditions

PeriodontitisDiabetes Mellitus

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • sandy Hassan, ass.prof

    associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Chronic periodontitis group chronic periodontitis with diabetes control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor oral medicine & periodontology departement

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 30, 2023

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 15, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

EG(2)