An interventional study of Surgical Periodontal Treatment and Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler. in Periodontitis and Type 2 Diabetes Mellitus, sponsored by University Clinical Centre of Kosova. Status unknown at 1 site in Kosovo. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-22.
Sponsored by University Clinical Centre of Kosova · Not applicable, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 160 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University Clinical Centre of Kosova is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 · 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%)
In the patient's with periodontal disease at least one tooth extraction will be performed.
Also known as: Tooth Extraction
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.
Also known as: FM-SRP
Drug page: Mouthwashes
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.
Also known as: Mouth wash
Biochemical parameter: HbA1c (mean value in %),
The changes in levels of glycated haemoglobin after periodontal treatment.
Time frame: 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.
Time frame: Baseline and 3 months after
Bleeding on probing (BOP) (expressed in %)
The changes in bleeding on probing after periodontal treatment.
Time frame: 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.
Time frame: Baseline and 3 months after
Plaque index (PI) (expressed in %)
The changes in plaque index after periodontal treatment.
Time frame: 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.
Time frame: Baseline and 3 months after
Plan to share: Undecided
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University Clinical Centre of Kosova