Periodontitis, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Oral Hygiene, Periodontal Surgery, Periodontal Medicine
Brief summary
This intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients.
Detailed description
In a randomize, prospective study 200 patients from the endocrinology department of Peja's Regional Hospital and Dental Polyclinic at city of Peja, will be assessed and examined for eligibility. Personal interviews will be used to collect the baseline data from each participant using a pre structured questionnaire. After clinical examination, 160 patients aged 30-70 years will be selected for the study. These will be further divided in four groups: type 2 diabetes mellitus group (with or without initial periodontal therapy) and non-diabetic group (with or without initial periodontal therapy). All the patients will be with periodontal disease and at least one tooth extraction will perform. Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus. Post operative rinsing will be followed with antiseptic solution Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) as a mouthwash thrice a day for 3 weeks.
Interventions
PROCEDURESurgical Periodontal Treatment
In the patient's with periodontal disease at least one tooth extraction will be performed.
DEVICENon Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.
Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.
Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) for the 3 weeks after tooth extraction and cleaning.
Sponsors
University of Ljubljana, Faculty of Medicine
University Clinical Centre of Kosova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 Diabetes Mellitus; having a baseline HbA1c ≥ 6.5%, at least 10 teeth in the functional dentition (excluding third molars) and a clinical diagnosis of periodontal disease with at least one site with probing depth (PD) ≥ 5mm, and two teeth with attachment lost ≥ 6mm and no modification in the pharmacological treatment of diabetes during the study period.
Exclusion criteria
* Pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical parameter: HbA1c (mean value in %), | Baseline and 3 months after | The changes in levels of glycated haemoglobin after periodontal treatment. |
| Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L) | Baseline and 3 months after | The changes in levels of c-reactive protein after periodontal treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) (expressed in %) | Baseline and 3 months after | The changes in bleeding on probing after periodontal treatment. |
| Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter) | Baseline and 3 months after | The changes in clinical attachment level after periodontal treatment. |
| Plaque index (PI) (expressed in %) | Baseline and 3 months after | The changes in plaque index after periodontal treatment. |
| Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter) | Baseline and 3 months after | The changes in probing pocket depth after periodontal treatment. |
Countries
Kosovo
Contacts
Primary ContactDashnor Bukleta, Dr
Outcome results
None listed