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

Primary Purpose

Periodontitis, Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Surgical Periodontal Treatment
Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.
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%)
Sponsored by
University Clinical Centre of Kosova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Diabetes, Oral Hygiene, Periodontal Surgery, Periodontal Medicine

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oral Surgery, Dental Polyclinic (HUCSK)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical periodontal treatment

Surgical and non-surgical periodontal treatment

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Biochemical parameter: HbA1c (mean value in %),
The changes in levels of glycated haemoglobin after periodontal treatment.
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.

Secondary Outcome Measures

Bleeding on probing (BOP) (expressed in %)
The changes in bleeding on probing after periodontal treatment.
Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
The changes in clinical attachment level after periodontal treatment.
Plaque index (PI) (expressed in %)
The changes in plaque index after periodontal treatment.
Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
The changes in probing pocket depth after periodontal treatment.

Full Information

First Posted
August 1, 2016
Last Updated
August 17, 2016
Sponsor
University Clinical Centre of Kosova
Collaborators
University of Ljubljana, Faculty of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02874963
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinical Centre of Kosova
Collaborators
University of Ljubljana, Faculty of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Type 2 Diabetes Mellitus
Keywords
Diabetes, Oral Hygiene, Periodontal Surgery, Periodontal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical periodontal treatment
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Surgical and non-surgical periodontal treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical Periodontal Treatment
Other Intervention Name(s)
Tooth Extraction
Intervention Description
In the patient's with periodontal disease at least one tooth extraction will be performed.
Intervention Type
Device
Intervention Name(s)
Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.
Other Intervention Name(s)
FM-SRP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
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%)
Other Intervention Name(s)
Mouth wash
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biochemical parameter: HbA1c (mean value in %),
Description
The changes in levels of glycated haemoglobin after periodontal treatment.
Time Frame
Baseline and 3 months after
Title
Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
Description
The changes in levels of c-reactive protein after periodontal treatment.
Time Frame
Baseline and 3 months after
Secondary Outcome Measure Information:
Title
Bleeding on probing (BOP) (expressed in %)
Description
The changes in bleeding on probing after periodontal treatment.
Time Frame
Baseline and 3 months after
Title
Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
Description
The changes in clinical attachment level after periodontal treatment.
Time Frame
Baseline and 3 months after
Title
Plaque index (PI) (expressed in %)
Description
The changes in plaque index after periodontal treatment.
Time Frame
Baseline and 3 months after
Title
Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
Description
The changes in probing pocket depth after periodontal treatment.
Time Frame
Baseline and 3 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dashnor Bukleta, Dr
Phone
+38649210317
Email
dashnor_bukleta@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dashnor Bukleta, Dr
Organizational Affiliation
Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oral Surgery, Dental Polyclinic (HUCSK)
City
Peja
ZIP/Postal Code
10000
Country
Kosovo
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheribane Anadolli, Dr
Phone
+38139433-291
Email
qshm_peja@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dashnor Bukleta, Dr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis

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