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Completed

NCT Number: NCT02745015

Effect of Non Surgical Treatment of Periodontitis on Diabetes Control

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.

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Key information

Conditions

Periodontitis Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Obesity Centre

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

full-mouth scaling and root planing

Primary outcomes

  1. Metabolic

    Time frame: 3 months

    Change in HbA1c

Secondary outcomes

  1. Inflammation

    Time frame: 3 months

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

  2. Periodontal 1

    Time frame: 3 months

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

  3. Periodontal 2

    Time frame: 3 months

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

  4. Periodontal 3

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study title

Effect of Non Surgical Treatment of Periodontitis on Glycaemic Control in a Type 2 Diabetic Populations of Cameroon

Acronym: PARODIA1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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