NCT03908606

Brief Summary

the aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

April 6, 2019

Last Update Submit

April 8, 2019

Conditions

Periodontal DiseaseDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • clinical attachment level

    gain in clinical attachment level

    3 months

Study Arms (3)

Periodontitis patients with diabetes type 2

EXPERIMENTAL

scaling and root planing was administered to all patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Glycated hemoglobin was measured before and after treatment

Procedure: Scaling and root planing

Periodontitis patients

EXPERIMENTAL

scaling and root planing will be done to periodontitis patients. Serum samples were collected before and after treatment to assess hs-CRP levels.

Procedure: Scaling and root planing

Healthy control group

NO INTERVENTION

We measured serum levels of hs-CRP in all healthy control subjects

Interventions

Scaling and root planingPROCEDURE

Supra and subgingival scaling and root planing.

Periodontitis patientsPeriodontitis patients with diabetes type 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients type 2
  • Periodontitis patients

You may not qualify if:

  • Smokers
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12411, Egypt

Location

MeSH Terms

Conditions

Periodontal DiseasesDiabetes Mellitus, Type 2

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Gihane Madkour, Prof

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 9, 2019

Study Start

April 11, 2018

Primary Completion

January 2, 2019

Study Completion

January 2, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)