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Trial record 3 of 11 for:    thymol

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

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ClinicalTrials.gov Identifier: NCT02874963
Recruitment Status : Unknown
Verified August 2016 by Dashor Bukleta, University Clinical Centre of Kosova.
Recruitment status was:  Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
University of Ljubljana, Faculty of Medicine
Information provided by (Responsible Party):
Dashor Bukleta, 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.

Condition or disease Intervention/treatment Phase
Periodontitis Type 2 Diabetes Mellitus 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%) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
Study Start Date : November 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Eucalyptol

Arm Intervention/treatment
Active Comparator: 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)

Procedure: Surgical Periodontal Treatment
In the patient's with periodontal disease at least one tooth extraction will be performed.
Other Name: Tooth Extraction

Active Comparator: Surgical and non-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
In the patient's with periodontal disease at least one tooth extraction will be performed.
Other Name: Tooth Extraction

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.
Other Name: 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%)
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.
Other Name: Mouth wash




Primary Outcome Measures :
  1. Biochemical parameter: HbA1c (mean value in %), [ Time Frame: Baseline and 3 months after ]
    The changes in levels of glycated haemoglobin after periodontal treatment.

  2. Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L) [ Time Frame: Baseline and 3 months after ]
    The changes in levels of c-reactive protein after periodontal treatment.


Secondary Outcome Measures :
  1. Bleeding on probing (BOP) (expressed in %) [ Time Frame: Baseline and 3 months after ]
    The changes in bleeding on probing after periodontal treatment.

  2. Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter) [ Time Frame: Baseline and 3 months after ]
    The changes in clinical attachment level after periodontal treatment.

  3. Plaque index (PI) (expressed in %) [ Time Frame: Baseline and 3 months after ]
    The changes in plaque index after periodontal treatment.

  4. Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter) [ Time Frame: Baseline and 3 months after ]
    The changes in probing pocket depth after periodontal treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874963


Contacts
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Contact: Dashnor Bukleta, Dr +38649210317 dashnor_bukleta@hotmail.com

Locations
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Kosovo
Oral Surgery, Dental Polyclinic (HUCSK) Recruiting
Peja, Kosovo, 10000
Contact: Sheribane Anadolli, Dr    +38139433-291    qshm_peja@hotmail.com   
Principal Investigator: Dashnor Bukleta, Dr         
Sponsors and Collaborators
University Clinical Centre of Kosova
University of Ljubljana, Faculty of Medicine
Investigators
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Principal Investigator: Dashnor Bukleta, Dr Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Publications:
Touger-Decker R, Schaefer M, Flinton R, Steinberg L. Effect of tooth loss and dentures On diet habits. J Prosthet Dent 1996;75:831.

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Responsible Party: Dashor Bukleta, Oral Surgery Specialist (PhD Candidate), University Clinical Centre of Kosova
ClinicalTrials.gov Identifier: NCT02874963     History of Changes
Other Study ID Numbers: HUCSK
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dashor Bukleta, University Clinical Centre of Kosova:
Diabetes
Oral Hygiene
Periodontal Surgery
Periodontal Medicine
Additional relevant MeSH terms:
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Thymol
Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ethanol
Listerine
Eucalyptol
Salicylates
Methyl salicylate
Menthol
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents