NCT04473209

Brief Summary

non-surgical periodontal debridement was performed for diabetic patients with chronic periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum resistin level was assessed in the two groups before and after periodontal therapy and also was compared to a healthy control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

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

September 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 12, 2020

Last Update Submit

July 14, 2020

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • serum resistin

    ng/ml

    3 months

Secondary Outcomes (3)

  • C-reactive protein

    3 months

  • probing pocket depth

    3 months

  • clinical attachment loss

    3 months

Study Arms (2)

diabetic group

ACTIVE COMPARATOR

diabetic patients with chronic periodontitis

Procedure: non-surgical periodontal therapy

non-diabetic group

ACTIVE COMPARATOR

non diabetic patients with chronic periodontitis

Procedure: non-surgical periodontal therapy

Interventions

non-surgical periodontal therapyPROCEDURE

supra and subgingival debridement

diabetic groupnon-diabetic group

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with moderate to severe chronic periodontitis.
  • Presence of a minimum of 15 natural teeth
  • Presence of at least four teeth with one or more sites with probing pocket depth (PPD) ≥5mm and clinical attachment level (CAL) ≥4mm
  • agreement to participate in the study and sign a written informed consent

You may not qualify if:

  • Patients who received any periodontal treatment or professional scaling and root planing of the teeth for at least 6 months prior to the study initiation
  • A history of antibiotics therapy and anti-inflammatory drugs within the previous 6 months
  • Pregnancy or use of contraceptives or any medication related to diabetes
  • former or current smokers ˂ 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11865, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group1: diabetic patients with chronic periodontitis group2: non diabetic patients with chronic periodontitis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Principal Investigator

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 16, 2020

Study Start

September 1, 2018

Primary Completion

September 30, 2019

Study Completion

January 30, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

EG(1)