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

Not Applicable

• Conditions: Periodontitis; Type 2 Diabetes Mellitus
• Interventions: 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%)

• Registration Number: NCT02874963
• Lead Sponsor: University Clinical Centre of Kosova

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.

Study Timeline

• Study Start: 2015-11
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-22
• Last Update Posted: 2016-08-22
• Primary Completion: 2016-09
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical periodontal treatment	Surgical Periodontal Treatment	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)
Surgical and non-surgical periodontal treatment	Surgical Periodontal Treatment	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.
Surgical and non-surgical periodontal treatment	Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.	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.
Surgical and non-surgical periodontal treatment	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%)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Oral Surgery, Dental Polyclinic (HUCSK); Peja, Kosovo