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CompletedNCT02745015PARODIA1Updated Jul 19, 2016

Effect of Non Surgical Treatment of Periodontitis on Diabetes Control

An interventional study of non-surgical periodontal treatment in Periodontitis and Diabetes, sponsored by Yaounde Central Hospital. Completed at 1 site in Cameroon. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-19.

Sponsored by Yaounde Central Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Periodontitis
  • Diabetes

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Keywords

  • periodontitis
  • diabetes
  • HbA1c
  • inflammation
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 45 is close to the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Yaounde Central Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Periodontal treatment in the last 6 months
  • antibiotics in the last 3 months
  • tobacco smoking
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    treatment

    immediate non-surgical periodontal treatment

    Procedure: non-surgical periodontal treatment

  • Other
    control

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

    Procedure: non-surgical periodontal treatment

Interventions

  • Procedurenon-surgical periodontal treatment

    full-mouth scaling and root planing

06

What researchers measure

Primary outcomes

  1. Metabolic

    Change in HbA1c

    Time frame: 3 months

Secondary outcomes

  1. Inflammation

    change in CRP level between baseline and 3-month post intervention

    Time frame: 3 months

  2. Periodontal 1

    Change in plaque index between baseline and 3-month post intervention

    Time frame: 3 months

  3. Periodontal 2

    Change in bleeding index between baseline and 3-month post intervention

    Time frame: 3 months

  4. Periodontal 3

    Change in pocket depth between baseline and 3-month post intervention

    Time frame: 3 months

07

Study locations

1 site
  • National Obesity Centre
    Yaounde, Cameroon
08

References and documents

Publications

  • 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. PubMed 29482543 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02745015
Lead sponsor
Yaounde Central Hospital
Responsible party
Sobngwi Eugene (Professor, Yaounde Central Hospital) — Principal investigator
First posted
Apr 20, 2016
Start date
Dec 2014
Primary completion
May 2015
Completion
May 2015
Last update
Jul 19, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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