Type 2 Diabetes Mellitus Clinical Trial
Official title:
Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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