NCT02745015

Brief Summary

The aim of this study is to investigate the effects of non-surgical periodontal treatment on the metabolic control of type2 diabetes patients. Patients with type two diabetes mellitus patients and confirmed chronic periodontitis will be selected and randomly assign to two groups. The treatment group will receive immediate full-mouth scaling and root planing whereas the control group will be scheduled to receive periodontal treatment at the following 3-month visit. Plaque index, bleeding index, probing pocket depth, recessions and cervical attachment loss will be recorded at baseline, at six weeks and at three months. Glycated haemoglobin (HbA1c) and C-reactive protein (CRP) will be analysed at baseline and three months following enrolment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

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

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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

April 16, 2016

Last Update Submit

July 17, 2016

Conditions

PeriodontitisDiabetes

Keywords

periodontitisdiabetesHbA1cinflammation

Outcome Measures

Primary Outcomes (1)

  • Metabolic

    Change in HbA1c

    3 months

Secondary Outcomes (4)

  • Inflammation

    3 months

  • Periodontal 1

    3 months

  • Periodontal 2

    3 months

  • Periodontal 3

    3 months

Study Arms (2)

treatment

EXPERIMENTAL

immediate non-surgical periodontal treatment

Procedure: non-surgical periodontal treatment

control

OTHER

non-surgical periodontal treatment scheduled for the following 3-monthly visit

Procedure: non-surgical periodontal treatment

Interventions

non-surgical periodontal treatmentPROCEDURE

full-mouth scaling and root planing

controltreatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes for at least one year
  • periodontitis
  • HbA1c \> 7%

You may not qualify if:

  • Periodontal treatment in the last 6 months
  • antibiotics in the last 3 months
  • tobacco smoking
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Obesity Centre

Yaoundé, Cameroon

Location

Related Publications (1)

  • Tsobgny-Tsague NF, Lontchi-Yimagou E, Nana ARN, Tankeu AT, Katte JC, Dehayem MY, Bengondo CM, Sobngwi E. Effects of nonsurgical periodontal treatment on glycated haemoglobin on type 2 diabetes patients (PARODIA 1 study): a randomized controlled trial in a sub-Saharan Africa population. BMC Oral Health. 2018 Feb 26;18(1):28. doi: 10.1186/s12903-018-0479-5.

    PMID: 29482543DERIVED

MeSH Terms

Conditions

PeriodontitisDiabetes MellitusInflammation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2016

First Posted

April 20, 2016

Study Start

December 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

CA(1)