FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis

Study Overview
=================
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.

Official Title
-----------------
Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Periodontitis, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: Surgical Periodontal Treatment
* Device: Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.
* Drug: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical periodontal treatment<br>Type 2 Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Non-Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Intervention: Procedure: Surgery (Tooth Extraction) | Procedure: Surgical Periodontal Treatment<br>* In the patient's with periodontal disease at least one tooth extraction will be performed.<br>* Other names: Tooth Extraction;|
| Active Comparator: Surgical and non-surgical periodontal treatment<br>Type 2 Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Non-Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Interventions: Procedure: Surgery (Tooth Extraction) Procedure: Non-surgical periodontal therapy-full mouth scaling and root planing (FM-SRP) with ultrasonic device and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus, post operative rinsing thrice a day for 3 weeks. | Procedure: Surgical Periodontal Treatment<br>* In the patient's with periodontal disease at least one tooth extraction will be performed.<br>* Other names: Tooth Extraction;Device: Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.<br>* 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.<br>* Other names: FM-SRP;Drug: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)<br>* 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.<br>* Other names: Mouth wash;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical parameter: HbA1c (mean value in %), | The changes in levels of glycated haemoglobin after periodontal treatment. | 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. | Baseline and 3 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing (BOP) (expressed in %) | The changes in bleeding on probing after periodontal treatment. | 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. | Baseline and 3 months after | 
| Plaque index (PI) (expressed in %) | The changes in plaque index after periodontal treatment. | 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. | Baseline and 3 months after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Oral Hygiene, Periodontal Surgery, Periodontal Medicine