NCT02874963|Unknown
FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis
Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
Loading search results
Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
Sponsor study identifier
interventional
160
0 countries
N/A
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 1, 2016
Actual (reported)August 22, 2016
Actual (reported)September 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
In the patient's with periodontal disease at least one tooth extraction will be performed.
Oral Surgery, Dental Polyclinic (HUCSK)
Peja, 10000, Kosovo
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.
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.
Dashnor Bukleta, Dr
Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
First Submitted
August 1, 2016
First Posted
August 22, 2016
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Loe H. Periodontal disease. The sixth complication of diabetes mellitus. Diabetes Care. 1993 Jan;16(1):329-34. No abstract available.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 22, 2016
Record last verified: 2016-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: