Clinical trial NCT02745015: Effect of Non Surgical Treatment of Periodontitis on Diabetes Control
Official title: Effect of Non Surgical Treatment of Periodontitis on Glycaemic Control in a Type 2 Diabetic Populations of Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diabetes
Keywords: periodontitis
diabetes
HbA1c
inflammation
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-20
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic
timeFrame: 3 months
Secondary outcomes:
measure: Inflammation
timeFrame: 3 months
measure: Periodontal 1
timeFrame: 3 months
measure: Periodontal 2
timeFrame: 3 months
measure: Periodontal 3
timeFrame: 3 months
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: National Obesity Centre
Study officials:
References:
citation: 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.