NCT02830113

Brief Summary

This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive protein(CRP) level amongst non-diabetic subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

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

December 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

July 8, 2016

Last Update Submit

July 8, 2016

Conditions

Keywords

periodontitisdiabetespreventionimpaired glucose toleranceinsulin resistance

Outcome Measures

Primary Outcomes (2)

  • Glucose tolerance

    change in 2-hour post load blood glucose

    3 months

  • Insulin sensitivity

    change in glucose disappearance rate during the short insulin tolerance test

    3 months

Secondary Outcomes (2)

  • Composite periodontal health

    3 months

  • Inflammation

    3 months

Study Arms (1)

non-surgical periodontal treatment

EXPERIMENTAL

One session of non-surgical periodontal treatment consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution.

Procedure: non-surgical periodontal treatment

Interventions

One session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution

non-surgical periodontal treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic periodontitis
  • Non diabetic individual

You may not qualify if:

  • Known diabetes
  • Having less than 20 natural teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nana Nana AR, Tsobgny Tsague NF, Lontchi-Yimagou E, Bengondo Messanga C, Tankeu A, Katte JC, Balti Vounsia E, Dehayem M, Sobngwi E. Effects of non-surgical treatment of chronic periodontitis on insulin resistance and glucose tolerance in subjects without diabetes (PARODIA 2 study). J Investig Med. 2021 Oct;69(7):1377-1381. doi: 10.1136/jim-2021-001831. Epub 2021 Jul 14.

MeSH Terms

Conditions

PeriodontitisPrediabetic StateDiabetes MellitusGlucose IntoleranceInsulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eugene Sobngwi, MD, PhD

    University of Yaoundé 1 and Yaoundé Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology and Diabetes

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 12, 2016

Study Start

December 1, 2014

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

July 12, 2016

Record last verified: 2016-07