FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis
17 augustus 2016 bijgewerkt door: Dashor Bukleta, University Clinical Centre of Kosova
Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
- Procedure: Surgical Periodontal Treatment
- Apparaat: Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.
- Geneesmiddel: 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%)
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
160
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Peja, Kosovo, 10000
- Werving
- Oral Surgery, Dental Polyclinic (HUCSK)
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Contact:
- Sheribane Anadolli, Dr
- Telefoonnummer: +38139433-291
- E-mail: qshm_peja@hotmail.com
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Hoofdonderzoeker:
- Dashnor Bukleta, Dr
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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) |
In the patient's with periodontal disease at least one tooth extraction will be performed.
Andere namen:
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Actieve vergelijker: 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. |
In the patient's with periodontal disease at least one tooth extraction will be performed.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Biochemical parameter: HbA1c (mean value in %),
Tijdsspanne: Baseline and 3 months after
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The changes in levels of glycated haemoglobin after periodontal treatment.
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Baseline and 3 months after
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Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
Tijdsspanne: Baseline and 3 months after
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The changes in levels of c-reactive protein after periodontal treatment.
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Baseline and 3 months after
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Bleeding on probing (BOP) (expressed in %)
Tijdsspanne: Baseline and 3 months after
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The changes in bleeding on probing after periodontal treatment.
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Baseline and 3 months after
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Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
Tijdsspanne: Baseline and 3 months after
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The changes in clinical attachment level after periodontal treatment.
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Baseline and 3 months after
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Plaque index (PI) (expressed in %)
Tijdsspanne: Baseline and 3 months after
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The changes in plaque index after periodontal treatment.
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Baseline and 3 months after
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Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
Tijdsspanne: Baseline and 3 months after
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The changes in probing pocket depth after periodontal treatment.
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Baseline and 3 months after
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Dashnor Bukleta, Dr, Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- Loe H. Periodontal disease. The sixth complication of diabetes mellitus. Diabetes Care. 1993 Jan;16(1):329-34. No abstract available.
- Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
- American Diabetes Association. Executive summary: Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S5-13. doi: 10.2337/dc14-S005. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Touger-Decker R, Schaefer M, Flinton R, Steinberg L. Effect of tooth loss and dentures On diet habits. J Prosthet Dent 1996;75:831.
- 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.
- Begzati A, Meqa K, Siegenthaler D, Berisha M, Mautsch W. Dental health evaluation of children in kosovo. Eur J Dent. 2011 Jan;5(1):32-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2015
Primaire voltooiing (Verwacht)
1 september 2016
Studie voltooiing (Verwacht)
1 oktober 2016
Studieregistratiedata
Eerst ingediend
1 augustus 2016
Eerst ingediend dat voldeed aan de QC-criteria
17 augustus 2016
Eerst geplaatst (Schatting)
22 augustus 2016
Updates van studierecords
Laatste update geplaatst (Schatting)
22 augustus 2016
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2016
Laatst geverifieerd
1 augustus 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Glucosemetabolismestoornissen
- Metabole ziekten
- Endocriene systeemziekten
- Stomatognatische ziekten
- Parodontale aandoeningen
- Mondziekten
- Suikerziekte
- Diabetes mellitus, type 2
- Parodontitis
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectiemiddelen, lokaal
- Anti-infectieuze middelen
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Cyclo-oxygenaseremmers
- Beschermende middelen
- Dermatologische middelen
- Agenten van het ademhalingssysteem
- Antischimmelmiddelen
- Antipruritica
- Antitussiva
- Insectenwerende middelen
- Ethanol
- Listerine
- Salicylaten
- Methylsalicylaat
- Menthol
- Thymol
- Eucalyptol
Andere studie-ID-nummers
- HUCSK
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Onbeslist
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