NCT02874963

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University Clinical Centre of Kosova · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	Surgical Periodontal Treatment	In the patient's with periodontal disease at least one tooth extraction will be performed.
DEVICE	Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.	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.
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%)	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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-08-22
• Last updated: 2016-08-22

Locations

1 site across 1 country: Kosovo