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

NCT02874963 | Unknown

• 1 other identifier: HUCSK
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Type 2 Diabetes Mellitus

Keywords

Diabetes; Oral Hygiene; Periodontal Surgery; Periodontal Medicine

Outcome Measures

Primary Outcomes (2)

• Biochemical parameter: HbA1c (mean value in %),

  The changes in levels of glycated haemoglobin after periodontal treatment.

  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.

  Baseline and 3 months after

Secondary Outcomes (4)

• Bleeding on probing (BOP) (expressed in %)

  Baseline and 3 months after

• Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)

  Baseline and 3 months after

• Plaque index (PI) (expressed in %)

  Baseline and 3 months after

• Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)

  Baseline and 3 months after

Study Arms (2)

Surgical periodontal treatment

ACTIVE COMPARATOR

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

Surgical and non-surgical periodontal treatment

ACTIVE COMPARATOR

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%)

Interventions

Surgical Periodontal Treatment PROCEDURE

In the patient's with periodontal disease at least one tooth extraction will be performed.

Also known as: Tooth Extraction

Surgical and non-surgical periodontal treatment; Surgical periodontal treatment

Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler. DEVICE

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

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%) DRUG

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

Surgical and non-surgical periodontal treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.

Sponsors & Collaborators

• University Clinical Centre of Kosova: lead
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

Oral Surgery, Dental Polyclinic (HUCSK)

Peja, 10000, Kosovo

RECRUITING

Related Publications (24)

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  PMID: 24357214 BACKGROUND

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  PMID: 10938048 BACKGROUND

• Zeqiri S, Ylli A, Zeqiri N. The effect of physical activity in glycemia in patients with diabetes mellitus. Med Arh. 2007;61(3):146-9.

  PMID: 18232276 BACKGROUND

• Jerliu N, Toci E, Burazeri G, Ramadani N, Brand H. Prevalence and socioeconomic correlates of chronic morbidity among elderly people in Kosovo: a population-based survey. BMC Geriatr. 2013 Mar 1;13:22. doi: 10.1186/1471-2318-13-22.

  PMID: 23452830 BACKGROUND

• Daci A, Elshani B, Giangiacomo B. Gestational diabetes mellitus (GDM) in the Republic of Kosovo: a retrospective pilot study. Med Arch. 2013;67(2):88-90. doi: 10.5455/medarh.2013.67.88-90.

  PMID: 24341050 BACKGROUND

• Albert DA, Ward A, Allweiss P, Graves DT, Knowler WC, Kunzel C, Leibel RL, Novak KF, Oates TW, Papapanou PN, Schmidt AM, Taylor GW, Lamster IB, Lalla E. Diabetes and oral disease: implications for health professionals. Ann N Y Acad Sci. 2012 May;1255:1-15. doi: 10.1111/j.1749-6632.2011.06460.x. Epub 2012 Mar 12.

  PMID: 22409777 BACKGROUND

• Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.

  PMID: 16881798 BACKGROUND

• Loe H. Periodontal disease. The sixth complication of diabetes mellitus. Diabetes Care. 1993 Jan;16(1):329-34. No abstract available.

  PMID: 8422804 BACKGROUND

• Tsai C, Hayes C, Taylor GW. Glycemic control of type 2 diabetes and severe periodontal disease in the US adult population. Community Dent Oral Epidemiol. 2002 Jun;30(3):182-92. doi: 10.1034/j.1600-0528.2002.300304.x.

  PMID: 12000341 BACKGROUND

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

  BACKGROUND

• Kamberi B, Hoxha V, Stavileci M, Dragusha E, Kuci A, Kqiku L. Prevalence of apical periodontitis and endodontic treatment in a Kosovar adult population. BMC Oral Health. 2011 Nov 29;11:32. doi: 10.1186/1472-6831-11-32.

  PMID: 22126237 BACKGROUND

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  PMID: 21228954 BACKGROUND

• Saremi A, Nelson RG, Tulloch-Reid M, Hanson RL, Sievers ML, Taylor GW, Shlossman M, Bennett PH, Genco R, Knowler WC. Periodontal disease and mortality in type 2 diabetes. Diabetes Care. 2005 Jan;28(1):27-32. doi: 10.2337/diacare.28.1.27.

  PMID: 15616229 BACKGROUND

• Pucher J, Stewart J. Periodontal disease and diabetes mellitus. Curr Diab Rep. 2004 Feb;4(1):46-50. doi: 10.1007/s11892-004-0011-y.

  PMID: 14764280 BACKGROUND

• Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. doi: 10.2337/diacare.24.3.561.

  PMID: 11289485 BACKGROUND

• Soskolne WA, Klinger A. The relationship between periodontal diseases and diabetes: an overview. Ann Periodontol. 2001 Dec;6(1):91-8. doi: 10.1902/annals.2001.6.1.91.

  PMID: 11887477 BACKGROUND

• Khader YS, Al Habashneh R, Al Malalheh M, Bataineh A. The effect of full-mouth tooth extraction on glycemic control among patients with type 2 diabetes requiring extraction of all remaining teeth: a randomized clinical trial. J Periodontal Res. 2010 Dec;45(6):741-7. doi: 10.1111/j.1600-0765.2010.01294.x.

  PMID: 20682017 BACKGROUND

• Nesto R. C-reactive protein, its role in inflammation, Type 2 diabetes and cardiovascular disease, and the effects of insulin-sensitizing treatment with thiazolidinediones. Diabet Med. 2004 Aug;21(8):810-7. doi: 10.1111/j.1464-5491.2004.01296.x.

  PMID: 15270782 BACKGROUND

• Paraskevas S, Huizinga JD, Loos BG. A systematic review and meta-analyses on C-reactive protein in relation to periodontitis. J Clin Periodontol. 2008 Apr;35(4):277-90. doi: 10.1111/j.1600-051X.2007.01173.x. Epub 2008 Feb 20.

  PMID: 18294231 BACKGROUND

• Grossi SG, Genco RJ. Periodontal disease and diabetes mellitus: a two-way relationship. Ann Periodontol. 1998 Jul;3(1):51-61. doi: 10.1902/annals.1998.3.1.51.

  PMID: 9722690 BACKGROUND

• Corbella S, Francetti L, Taschieri S, De Siena F, Fabbro MD. Effect of periodontal treatment on glycemic control of patients with diabetes: A systematic review and meta-analysis. J Diabetes Investig. 2013 Sep 13;4(5):502-9. doi: 10.1111/jdi.12088. Epub 2013 Apr 18.

  PMID: 24843701 BACKGROUND

• Kiran M, Arpak N, Unsal E, Erdogan MF. The effect of improved periodontal health on metabolic control in type 2 diabetes mellitus. J Clin Periodontol. 2005 Mar;32(3):266-72. doi: 10.1111/j.1600-051X.2005.00658.x.

  PMID: 15766369 BACKGROUND

• Teeuw WJ, Gerdes VE, Loos BG. Effect of periodontal treatment on glycemic control of diabetic patients: a systematic review and meta-analysis. Diabetes Care. 2010 Feb;33(2):421-7. doi: 10.2337/dc09-1378.

  PMID: 20103557 BACKGROUND

• Wang X, Han X, Guo X, Luo X, Wang D. The effect of periodontal treatment on hemoglobin a1c levels of diabetic patients: a systematic review and meta-analysis. PLoS One. 2014 Sep 25;9(9):e108412. doi: 10.1371/journal.pone.0108412. eCollection 2014.

  PMID: 25255331 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Tooth Extraction; Listerine; Ethanol; methyl salicylate; Menthol; Thymol; Mouthwashes

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Alcohols; Organic Chemicals; Cyclohexanols; Hexanols; Fatty Alcohols; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Dashnor Bukleta, Dr

  Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dashnor Bukleta, Dr

CONTACT

+38649210317; dashnor_bukleta@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral Surgery Specialist (PhD Candidate)

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 22, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

KO (1)