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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
In the patient's with periodontal disease at least one tooth extraction will be performed.
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.
Oral Surgery, Dental Polyclinic (HUCSK)
Peja, Kosovo
RECRUITINGBiochemical parameter: HbA1c (mean value in %),
The changes in levels of glycated haemoglobin after periodontal treatment.
Time frame: Baseline and 3 months after
Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
The changes in levels of c-reactive protein after periodontal treatment.
Time frame: Baseline and 3 months after
Bleeding on probing (BOP) (expressed in %)
The changes in bleeding on probing after periodontal treatment.
Time frame: Baseline and 3 months after
Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
The changes in clinical attachment level after periodontal treatment.
Time frame: Baseline and 3 months after
Plaque index (PI) (expressed in %)
The changes in plaque index after periodontal treatment.
Time frame: Baseline and 3 months after
Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
The changes in probing pocket depth after periodontal treatment.
Time frame: Baseline and 3 months after
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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.