Clinical trial NCT02874963: FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis
Official title: Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Type 2 Diabetes Mellitus
Keywords: Diabetes
Oral Hygiene
Periodontal Surgery
Periodontal Medicine
Lead sponsor: University Clinical Centre of Kosova
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
First posted: 2016-08-22
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical parameter: HbA1c (mean value in %),
timeFrame: Baseline and 3 months after
measure: Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
timeFrame: Baseline and 3 months after
Secondary outcomes:
measure: Bleeding on probing (BOP) (expressed in %)
timeFrame: Baseline and 3 months after
measure: Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
timeFrame: Baseline and 3 months after
measure: Plaque index (PI) (expressed in %)
timeFrame: Baseline and 3 months after
measure: Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
timeFrame: Baseline and 3 months after
Other outcomes:
Locations:
city: Peja
country: Kosovo
facility: Oral Surgery, Dental Polyclinic (HUCSK)
Study officials:
affiliation: Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
name: Dashnor Bukleta, Dr
role: PRINCIPAL_INVESTIGATOR
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